FINALLY Staged, Timing of 2nd opinion (with Clinical Trial option complicating matters)

[lakeswim]

... Would you say radiation side effects are much worse than chemo - or does that highly depend? And must I even DO radiation? ...

I don't really know, but I think it probably depends. I noticed on the clinical trial's protocol that they will be using IMRT (Intensity Modulated Radiation Therapy) for the radiation phase. This procedure allows the radiation oncologist to target which parts of which organs receive the full intensity radiation, and which organs receive minimal radiation. Since your tumor is on the anterior wall of the rectum at the second haustral fold, this suggests that your radiation will be focused mainly in that area, which is very close to the uterus and not too far away from the upper part of the vagina (see diagram below). This may mean that there might be some collateral radiation damage to the female uro-genital area.

Diagram:
http://www.stepwards.com/wp-content/uploads/2016/06/Urogenital-system-female-anatomy-photographs-sacrum-ureter-rectum-uterus-posterior-fornix-vagina-rectouterine-pouch-levator-ani-muscle-cervix-anus-cl.jpg

Here is some information on IMRT and radiation:

Targeted rectal radiation: IMRT / IGRT
http://coloncancersupport.colonclub.com/viewtopic.php?f=1&t=48936&p=372445#p372445

GOOD STUFF! Thank you! As usual, you have great info and I can't wait to return from Cleveland and review it all and follow up with questions. I BELIEVE that I will get targeted radiation regardless of whether or not I am on the trial. (They kept saying it would be "same treatment" - just flipped.) But a good question to ask both in my appt tomorrow and in f/u discussions on the trial with my team here.

I assume when I return, I will ALSO have more questions about deciding on second opinions - and traveling for parts of treatment. I will have to search for links on that but if you have any advice, I appreciate it.

Thank you - as always - for your help and support.

[O Stoma Mia]

... I will ALSO have more questions about deciding on second opinions - and traveling for parts of treatment. I will have to search for links on that but if you have any advice, I appreciate it..

... Based on the convo with the rad onc and the onc on Thursday, I felt more positive about it (because they said I'd get "special treatment" and " more monitoring" during and after treatment AND that they'd be held to higher standards given the clinical trial board needs to review/check everything AND because I may end up doing same thing we had planned to do - if I'm in one of the randomized groups) ...

There are several points you might want some clarification on.

1. Where will you have to go to get this "special treatment' and "more monitoring? Will you have to travel all the way to the study center for each extra intervention or monitoring event that they want to do over the next three years?

2. How often will you have to show up in person at the study center to obtain these extra items? Once a week? Twice a week? Once a month for the next 3 years (until the end of the followup period)?

3. Who pays for these extra treatments and these extra monitoring sessions? You? The hospital? Your insurance?

4. What if you or your doctor don't think that all of these extra tests are worth the cost and effort? Will your doctor still be forced to order you to have them because he/she is being held to these "higher standards"?

The reason I mention this is because there was a case a few years ago where someone signed up for a clinical trial and then found out afterwards that he was expected to show up at the study center several times a week over the course of treatment to have blood drawn to detect the concentration of chemo in the blood over time. At the same time, there was only one scan planned for assessing the size/shrinkage of the tumor, and that was at the very end of the treatment period. This is not what he had expected would happen, but this is what the research protocol required and this is what they had to do.

These are the kinds of questions you have to ask. You have to ask for all of the details that they forgot to talk about.

-

Also, here is a list of questions from the Cleveland Clinic website:

Important questions to ask before deciding to participate in a study:
• Why is the study being done?
• How long will my participation in the study last?
• Will I be receiving treatment or just providing information?
• If I receive treatment, how will it be given (pill, IV, implant, etc.)?
• How many visits will I make? Where do the visits take place? How much timedoes each visit take?
• Do I have to pay for any part of the study?
• Will my insurance cover any parts of the study?
• What are the risks of the study?
• What will happen to my medical care if I choose not to participate or withdraw from the study?
• Does the Investigator benefit if I participate?
• Who will be in charge of my care?
Reference: https://my.clevelandclinic.org/-/scassets/files/org/research/research-brochure.ashx?la=en

[Eleda]

Lakeswim, I cant answer for chemotherapy because im.just awaiting surgery Thursday but im.also same age and had very little sude effects from radiation ( long term that im aware of)

During it I had bad urethra burning ( still stings a little) nothing I cant live with
Bad dioreah from about week 3 ( sore bum poo about 7 times a day with urgency)shower ur bum after each poo, the skin becomes so thin its sore to touch and prob hemmies too just to add to things lol get a sitz bath!!!!!! Ull thank me lol!!!!!!!
Loss of period since jan( im ok with that lol)done wirh babiemaking

All have now returned to normal ( accept stinging urethra when having a pee for about 3seconds) no biggie!!!!

Luckely I had no skin breakdown, and my oncologists gave me antisick tab to start before Xleoda,,
He said its better to avoid the nasausa as once it kicks in its, hard to get under control
Good luch with ur decission
ADELE

[lakeswim]

Thank you, Eleda and O Stoma Mia, for your notes and perspectives.

I went to Cleveland yesterday - and BOY, is that place impressive. The surgeon (the reason I made the trip) told me flat out - forget the clinical trial if you are nervous. Just make your decisions based on YOU. Phew - ok - permission to forget about it. But you make good points, O Stoma Mia. I don't see enough of a benefit to participating. So, yes, I feel extreme relief just dropping the trial subject entirely.

Cleveland told me they were sending my case to their tumor board so should hear definitively in a few days.(Meanwhile, I was supposed to start Chemo/FOLFOX yesterday here.) I feel nervous about waiting (this is taking forever) but also eager to hear their official recommendations.

So, I have questions about their perspective.
1) PROTOCOL? Cleveland team is (tentatively) telling me Chemo/radiation FIRST - then (mostly likely, but not definitely) TME/Neorectum surgery - then (perhaps) chemo (with the possibility of avoiding Oxyplatin (sp?)!!). Here at home, they told me FOLFOX chemo (so, definitely with Oxy) FIRST - then chemoradiation - and then (mostly likely, but not definitely) surgery (no details on their surgical plans). (Watch and wait was mentioned by both teams but onc at Cleveland doesn't love that option as he sees patients returning when not careful with monitoring.) Why the difference in order with these protocols? Both tell me it's the standard/accepted protocol? Is my home team ahead of the curve - or just different opinions? Is there any benefit to doing it either way? Neither team says I can avoid radiation because of my T4.

2) TYPE OF SURGERY? The surgeon in Cleveland wants to do a TME - NEORECTUM. Is this a Jpouch? He also wants to remove my uterus (as tumor is getting close into it) and my ovaries. The onc in Cleveland suggested dealing with my liver adenoma while they are at it. I haven't had time to fully research the neorectum, but what is the benefit of this compared to other options (anastomosis?). This was never mentioned by my surgeon here, but in her defense, I met her FIRST before we had any info. at all. So, could be the same. Sounds extreme, given my tumor is higher up, but he explained it well. Why do I need all the rectum taken? (He mentioned that leaving so little can cause more problems?). Any ideas? Is this normal? He said a neorectum means only more frequency - not really any other issues.

3) Protocol with 2nd opinion: Do I share the second opinion with my team here? I'm thinking yes. Not sure whether to wait until I hear from Cleveland or tell them the tentative info.

4) Traveling for Radiation/Second Opinion locally for Rad Onc. I love the rad onc at Cleveland. She's a woman and was ready and willing to discuss female issues that can arise from radiation. She was so young (!!!!) - as they all seem to be - but she was a far cry from the doc here who didn't even mention any real side effects for females from the radiation. Do I ask for a meeting with a different rad onc here? (Living elsewhere for 5-6 weeks seems an extreme option. Not sure benefits would outweigh the stress of being away from my kids/family.) Rad Onc @Cleveland said she thinks Rad Oncs who are younger have more knowledge of newer procedures so the age of the Rad Onc isn't necessarily meaningful (young may be better!)

Thank you for your help.

[lakeswim]

... I will ALSO have more questions about deciding on second opinions - and traveling for parts of treatment. I will have to search for links on that but if you have any advice, I appreciate it..

... Based on the convo with the rad onc and the onc on Thursday, I felt more positive about it (because they said I'd get "special treatment" and " more monitoring" during and after treatment AND that they'd be held to higher standards given the clinical trial board needs to review/check everything AND because I may end up doing same thing we had planned to do - if I'm in one of the randomized groups) ...

There are several points you might want some clarification on.


These are the kinds of questions you have to ask. You have to ask for all of the details that they forgot to talk about.

[/quote]

Not sure how to bump up my previous post to get feedback so I am quoting here in the hopes someone sees this and my previous post. (Should I create new post?) I have a few questions to add to the ones in my last post (that I hope people will look at too!):

1) Is there an advantage in doing chemo>c/rad>surgery (vs. c/rad>surgery>chemo) in that you're not dealing with digestive consequences of chemo when you are post-surgery and have brand new "plumbing"? I ASSUME chemo side effects (constipation and/or diarrhea) would be easier on a system when the plumbing is still original vs. when it's all modified and you're already dealing with the change. Any experience with this?

2) One place is saying no chemo (or no chemo up front) b/c cancer is not metastasized - yet the same place is saying definitely c/rad and a TME (taking uterus and creating neorectum) because I'm T4 and there may be cancer circulating in my pelvis. Yet, the other place is saying chemo is necessary BECAUSE I am T4 and cancer could be circulating everywhere. So, how do they know how far the "free range" cancer cells are going? I mean, how do they know they may only be limited to pelvis when they could be everywhere, if the tumor has already (or nearly) breached uterus wall?

3) Watch and wait. I want to read more about this. I'm betting there is a good post here somewhere on the benefits and drawbacks. While surgery is scary, more cancer popping up is scarier.

Thank you so much!

[O Stoma Mia]

...
So, I have questions about their perspective.
1) PROTOCOL? Cleveland team is (tentatively) telling me Chemo/radiation FIRST - then (mostly likely, but not definitely) TME/Neorectum surgery - then (perhaps) chemo (with the possibility of avoiding Oxyplatin (sp?)!!). Here at home, they told me FOLFOX chemo (so, definitely with Oxy) FIRST - then chemoradiation - and then (mostly likely, but not definitely) surgery (no details on their surgical plans). (Watch and wait was mentioned by both teams but onc at Cleveland doesn't love that option as he sees patients returning when not careful with monitoring.) Why the difference in order with these protocols? Both tell me it's the standard/accepted protocol? Is my home team ahead of the curve - or just different opinions? Is there any benefit to doing it either way? Neither team says I can avoid radiation because of my T4.

2) TYPE OF SURGERY? The surgeon in Cleveland wants to do a TME - NEORECTUM. Is this a Jpouch? He also wants to remove my uterus (as tumor is getting close into it) and my ovaries. The onc in Cleveland suggested dealing with my liver adenoma while they are at it. I haven't had time to fully research the neorectum, but what is the benefit of this compared to other options (anastomosis?). This was never mentioned by my surgeon here, but in her defense, I met her FIRST before we had any info. at all. So, could be the same. Sounds extreme, given my tumor is higher up, but he explained it well. Why do I need all the rectum taken? (He mentioned that leaving so little can cause more problems?). Any ideas? Is this normal? He said a neorectum means only more frequency - not really any other issues.

3) Protocol with 2nd opinion: Do I share the second opinion with my team here? I'm thinking yes. Not sure whether to wait until I hear from Cleveland or tell them the tentative info.

4) Traveling for Radiation/Second Opinion locally for Rad Onc. I love the rad onc at Cleveland. She's a woman and was ready and willing to discuss female issues that can arise from radiation. She was so young (!!!!) - as they all seem to be - but she was a far cry from the doc here who didn't even mention any real side effects for females from the radiation. Do I ask for a meeting with a different rad onc here? (Living elsewhere for 5-6 weeks seems an extreme option. Not sure benefits would outweigh the stress of being away from my kids/family.) Rad Onc @Cleveland said she thinks Rad Oncs who are younger have more knowledge of newer procedures so the age of the Rad Onc isn't necessarily meaningful (young may be better!)

Thank you for your help.

To answer some of your questions, I would like to refer you to the NCCN Guideline for Rectal Cancer, which is the main document used in the US for establishing the current "standards of care" for rectal cancer. It is a 153-page document, but only 4 of these pages are relevant at this time for your T4N0M0 case.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Rectal Cancer, Version 3.2017, March 2017, 153pp

The 4 sections relevant for you are found on pages 11, 14, 27, and 32:

• Section REC-2, p. 11, Rectal Cancers Appropriate for Resection
  Your case falls in the category T4N0, which is the second upward arrow, and which then points to the Primary Treatment Section REC-4 on p. 14
• Section REC-4, p. 14, Primary Treatment Options
  This section shows that T4N0M0 has two main options for first treatment. The first block shows the 'radiation-first' group of choices. They call it 'long-course Chemo/RT'.
  
  The third block shows the 'chemo-first' group of choices. This group contains the standard FOLFOX, and XELOX(CAPEOX) regimens. (The second block called 'short-course Chemo-RT' is not available for T4 cases). So, according to NCCN, either 'radiation-first' or 'chemo-first' can qualify as first-line 'standard of care'.
  
  However, these two first-line options differ in what they then require as the next intervention: For the radiation-first group, the second intervention must be surgery, followed only later on by adjuvant chemotherapy. For the chemo-first group, the second intervention must be the radiation treatment, followed only later by surgery.
  
  This REC-4 chart is a bit complicated, but what you can conclude from it is that the Cleveland Clinic protocol fits exactly within the NCCN guidelines, whereas the protocol recommended by your local hospital does not. The sequence that your local hospital wants to follow does not totally fit within the NCCN standard. This does not necessarily mean that their protocol is less worthy. In fact it might mean that they are proposing something that will eventually turn out to be "ahead of the curve". What it means, really, is that their proposed protocol is still experimental in nature, lacking definitive proof that it is equivalent to, or better than, the alternative.
  
  I think that this might explain why they are so eager to enroll patients in their clinical trial. If this trial turns out to be successful, then they will have the evidence that they need to support their specific protocol. For now, however, it seems that they don't yet have the necessary clinical-trial based evidence to support their choice of protocol.
  
  Another point concerns the 'wait and watch' option. NCCN calls this the 'Observation' option. For NCCN, this option is available for T3N0M0 patients, but not for T4N0M0 patients.
  .
• Section REC-B. p. 27. Principals of Surgery
  For surgery, NCCN recommends transabdominal resection, which in your case would be a standard TME done in the context of an open LAR surgery, or lap-assisted LAR surgery. I don't know exactly what Cleveland Clinic means by Neorectum, but my understanding is that the standard surgery would involve a sigmoid colon -to- rectal stump straight through connection where the connection would be called the anastomosis, and the part of the sigmoid colon brought down to make the connection would be called the 'neo-rectum' because it is then located where the resected rectum used to be. If they want to do a J-pouch instead, I think they should be explicit about this. This type of connection might be called a colo-anal anastomosis -- I'm not sure
  
  Total Mesorectal Excision (TME) surgery is fairly well defined and involves removing the part of the rectum from where the mesorectum starts up near the recto-sigmoid junction, all the way down to where the mesorectum stops. This usually involves the upper 2/3 of the rectum, leaving about 1/3 of the rectum as a rectal stump. This has become the standard way of dealing with rectal tumors where the tumor is somewhere in the upper 2/3 of the rectum.
  .
• Section REC-D, p. 32 Principals of Radiation
  You can read this section to see what is within the standard for rectal cancer radiation. The standard mentions the need to consider female side effects, so it might be worthwhile to look for a rad/onc who will be able to set up the radiation profile to suit your needs. The new generation linear accelerators are controlled by computers with sophisticated Artificial Intelligence software that can recognize organs and structures and can deliver appropriate radiation accordingly. This requires a rad/onc who is very knowledgeable in rectal anatomy, rectal cancer, targeted radiation, as well as AI computer software. The older generation rad/oncs may not be quite up to speed with all of this.

[lakeswim]

... Would you say radiation side effects are much worse than chemo - or does that highly depend? And must I even DO radiation? ...

I don't really know, but I think it probably depends. I noticed on the clinical trial's protocol that they will be using IMRT (Intensity Modulated Radiation Therapy) for the radiation phase. This procedure allows the radiation oncologist to target which parts of which organs receive the full intensity radiation, and which organs receive minimal radiation. Since your tumor is on the anterior wall of the rectum at the second haustral fold, this suggests that your radiation will be focused mainly in that area, which is very close to the uterus and not too far away from the upper part of the vagina (see diagram below). This may mean that there might be some collateral radiation damage to the female uro-genital area.

Diagram:
http://www.stepwards.com/wp-content/uploads/2016/06/Urogenital-system-female-anatomy-photographs-sacrum-ureter-rectum-uterus-posterior-fornix-vagina-rectouterine-pouch-levator-ani-muscle-cervix-anus-cl.jpg

Here is some information on IMRT and radiation:

Targeted rectal radiation: IMRT / IGRT
http://coloncancersupport.colonclub.com/viewtopic.php?f=1&t=48936&p=372445#p372445

GOOD STUFF! Thank you! As usual, you have great info and I can't wait to return from Cleveland and review it all and follow up with questions. I BELIEVE that I will get targeted radiation regardless of whether or not I am on the trial. (They kept saying it would be "same treatment" - just flipped.) But a good question to ask both in my appt tomorrow and in f/u discussions on the trial with my team here.

I assume when I return, I will ALSO have more questions about deciding on second opinions - and traveling for parts of treatment. I will have to search for links on that but if you have any advice, I appreciate it.

Thank you - as always - for your help and support.

Thank you. I will look up these pages and research and ask more pointed questions - probably about surgery.

May I just add that I must have communicated poorly at some point. Cleveland is not the group who wants to do the trial (they want to do c/rad>surgery>then maybe chemo). It is/was the group here at home (who want to do chemo>c/rad>surgery) that want to do the clinical trial (but I am just dropping the trial idea entirely).

Thank you!

[lakeswim]

...
So, I have questions about their perspective.
1) PROTOCOL? Cleveland team is (tentatively) telling me Chemo/radiation FIRST - then (mostly likely, but not definitely) TME/Neorectum surgery - then (perhaps) chemo (with the possibility of avoiding Oxyplatin (sp?)!!). Here at home, they told me FOLFOX chemo (so, definitely with Oxy) FIRST - then chemoradiation - and then (mostly likely, but not definitely) surgery (no details on their surgical plans). (Watch and wait was mentioned by both teams but onc at Cleveland doesn't love that option as he sees patients returning when not careful with monitoring.) Why the difference in order with these protocols? Both tell me it's the standard/accepted protocol? Is my home team ahead of the curve - or just different opinions? Is there any benefit to doing it either way? Neither team says I can avoid radiation because of my T4.

2) TYPE OF SURGERY? The surgeon in Cleveland wants to do a TME - NEORECTUM. Is this a Jpouch? He also wants to remove my uterus (as tumor is getting close into it) and my ovaries. The onc in Cleveland suggested dealing with my liver adenoma while they are at it. I haven't had time to fully research the neorectum, but what is the benefit of this compared to other options (anastomosis?). This was never mentioned by my surgeon here, but in her defense, I met her FIRST before we had any info. at all. So, could be the same. Sounds extreme, given my tumor is higher up, but he explained it well. Why do I need all the rectum taken? (He mentioned that leaving so little can cause more problems?). Any ideas? Is this normal? He said a neorectum means only more frequency - not really any other issues.

3) Protocol with 2nd opinion: Do I share the second opinion with my team here? I'm thinking yes. Not sure whether to wait until I hear from Cleveland or tell them the tentative info.

4) Traveling for Radiation/Second Opinion locally for Rad Onc. I love the rad onc at Cleveland. She's a woman and was ready and willing to discuss female issues that can arise from radiation. She was so young (!!!!) - as they all seem to be - but she was a far cry from the doc here who didn't even mention any real side effects for females from the radiation. Do I ask for a meeting with a different rad onc here? (Living elsewhere for 5-6 weeks seems an extreme option. Not sure benefits would outweigh the stress of being away from my kids/family.) Rad Onc @Cleveland said she thinks Rad Oncs who are younger have more knowledge of newer procedures so the age of the Rad Onc isn't necessarily meaningful (young may be better!)

Thank you for your help.

To answer some of your questions, I would like to refer you to the NCCN Guideline for Rectal Cancer, which is the main document used in the US for establishing the current "standards of care" for rectal cancer. It is a 153-page document, but only 4 of these pages are relevant at this time for your T4N0M0 case.

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Rectal Cancer, Version 3.2017, March 2017, 153pp

The 4 sections relevant for you are found on pages 11, 14, 27, and 32:

• Section REC-2, p. 11, Rectal Cancers Appropriate for Resection
  Your case falls in the category T4N0, which is the second upward arrow, and which then points to the Primary Treatment Section REC-4 on p. 14
• Section REC-4, p. 14, Primary Treatment Options
  This section shows that T4N0M0 has two main options for first treatment. The first block shows the 'radiation-first' group of choices. They call it 'long-course Chemo/RT'.
  
  The third block shows the 'chemo-first' group of choices. This group contains the standard FOLFOX, and XELOX(CAPEOX) regimens. (The second block called 'short-course Chemo-RT' is not available for T4 cases). So, according to NCCN, either 'radiation-first' or 'chemo-first' can qualify as first-line 'standard of care'.
  
  However, these two first-line options differ in what they then require as the next intervention: For the radiation-first group, the second intervention must be surgery, followed only later on by adjuvant chemotherapy. For the chemo-first group, the second intervention must be the radiation treatment, followed only later by surgery.
  
  This REC-4 chart is a bit complicated, but what you can conclude from it is that the Cleveland Clinic protocol fits exactly within the NCCN guidelines, whereas the protocol recommended by your local hospital does not. The sequence that your local hospital wants to follow does not totally fit within the NCCN standard. This does not necessarily mean that their protocol is less worthy. In fact it might mean that they are proposing something that will eventually turn out to be "ahead of the curve". What it means, really, is that their proposed protocol is still experimental in nature, lacking definitive proof that it is equivalent to, or better than, the alternative.
  
  I think that this might explain why they are so eager to enroll patients in their clinical trial. If this trial turns out to be successful, then they will have the evidence that they need to support their specific protocol. For now, however, it seems that they don't yet have the necessary clinical-trial based evidence to support their choice of protocol.
  
  Another point concerns the 'wait and watch' option. NCCN calls this the 'Observation' option. For NCCN, this option is available for T3N0M0 patients, but not for T4N0M0 patients.
  .
• Section REC-B. p. 27. Principals of Surgery
  For surgery, NCCN recommends transabdominal resection, which in your case would be a standard TME done in the context of an open LAR surgery, or lap-assisted LAR surgery. I don't know exactly what Cleveland Clinic means by Neorectum, but my understanding is that the standard surgery would involve a sigmoid colon -to- rectal stump straight through connection where the connection would be called the anastomosis, and the part of the sigmoid colon brought down to make the connection would be called the 'neo-rectum' because it is then located where the resected rectum used to be. If they want to do a J-pouch instead, I think they should be explicit about this. This type of connection might be called a colo-anal anastomosis -- I'm not sure
  
  Total Mesorectal Excision (TME) surgery is fairly well defined and involves removing the part of the rectum from where the mesorectum starts up near the recto-sigmoid junction, all the way down to where the mesorectum stops. This usually involves the upper 2/3 of the rectum, leaving about 1/3 of the rectum as a rectal stump. This has become the standard way of dealing with rectal tumors where the tumor is somewhere in the upper 2/3 of the rectum.
  .
• Section REC-D, p. 32 Principals of Radiation
  You can read this section to see what is within the standard for rectal cancer radiation. The standard mentions the need to consider female side effects, so it might be worthwhile to look for a rad/onc who will be able to set up the radiation profile to suit your needs. The new generation linear accelerators are controlled by computers with sophisticated Artificial Intelligence software that can recognize organs and structures and can deliver appropriate radiation accordingly. This requires a rad/onc who is very knowledgeable in rectal anatomy, rectal cancer, targeted radiation, as well as AI computer software. The older generation rad/oncs may not be quite up to speed with all of this.

I'm clearly not doing a good job of communicating today. Cleveland surgeon said "neorectum". I thought this was the same as a J pouch (he described it like it was shaped like a J so I made that assumption) so perhaps he's not proposing a J pouch - if that's indeed different. But the neorectum word was mentioned various times so that's for sure. Thank you.

[lakeswim]

This is such great information. I am grateful you took the time to explain it. Thank you so much!!