I have a rather different interpretation about your situation there, but before I go into a long discourse about this I would like to ask whether you are, in fact, a registered patient in the PROSPECT trial and,if so, did they ask you to sign an Informed Consent document for that particular trial? The alternative might be that you were treated off-the-record according to the PROSPECT trial protocol but were not actually registered as one of their patients.
The difference is that if you are registered as an official member of that trial, then they are obligated to follow the protocol for that trial,
but if you are just an ordinary, unregistered, patient for whom they decided to try the PROSPECT protocol, then they are not required to follow the protocol to the letter.
In my opinion, there are two documents that are particularly relevant in your case.
The particular paragraphs of interest in these two documents are the following:
- From the PROSPECT trial protocol, Arm 1, it says:
Experimental: Group 1
Patients will receive FOLFOX chemotherapy once every two weeks for 6 cycles total over a period of 12 weeks. After completing FOLFOX chemotherapy, the patient will have an MRI scan or endorectal ultrasound (ERUS) to examine the tumor. If the tumor has not decreased in size by at least 20%, the patient will receive 5FUCMT (radiation with chemotherapy). If the tumor has decreased in size by 20%, then the patient will proceed directly to surgery.
If all borders of the tumor are normal post surgery, then the patient receives six additional cycles of FOLFOX chemotherapy. If all borders of the tumor are not normal then the patient receives chemoradiation therapy for 5.5 weeks after surgery. After chemoradiation, additional cycles of FOLFOX or similar chemotherapy will be recommended for 4 cycles or 8 weeks. Patient observation with follow up evaluations and event monitoring will occur up to 8 years post randomization.
- From Federal Law 21CFR50.25(a)(8) on Informed Consent it says.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
This could turn out to be a long involved discussion, but to summarize, I think the issue is this:
Your surgeon is Principal Investigator of this clinical trial for 5 MD Anderson hospitals in Texas, and as Principal Investigator he is responsible for conducting the trial according to the protocol and for following the protocol to the letter for each patient that he enrolls in the trial.
Basically, the dilemma is this: If your surgeon lets you off the hook by saying "No more chemo for you" he is violating the protocol. (That's my opinion)
Keep in mind that clinical trials are there for a purpose. They are there to conduct studies under controlled
conditions so that the eventual findings are scientifically valid. The controlled conditions mean that if you are assigned to a group that requires post surgery chemo, then all persons in that group will have to have post surgery chemo. This is so that the findings can be scientifically valid.
The other part of the dilemma is that if you are a patient in the trial and you decide to invoke the option of Federal Law Federal Law 21CFR50.25(a)(8) then you are no longer in the trial and your data must be censored
when it comes time to do the final statistical analysis -- in other words, if you invoke your right to leave the trial so that you can skip post-surgery chemo, then you become a trial drop-out and the number of patients analyzed in the trial is decreased accordingly.
So, what I'm saying is that there is a certain conflict of interest here: The surgeon is interested, of course, in being a good Principal Investigator, but at the same time he is interested in doing the best for his patient vis-à-vis
long-term quality of life.
So, from my point of view the decision is ultimately up to you and your surgeon to resolve this apparent dilemma.