Clinical Trials Selection for Adjuvant Therapy
Since my tumor was discovered I haven't seen a medical oncologist. I went straight to our university urology department and saw the surgeon and he advised a radical nephrectomy. From my reading, and talking to my uncle, who is a medical oncologist, although retired about 7 years, it looked clear that it had to come out. I didn't get second opinions.
Now that the tumor is removed, I'm looking around at clinical trials to see if there's anything that could help reduce my chances of recurrence, which appears to be quite high with my stage and grade.
There are 2 in my area that are available (possibly a third). I'm trying now to get into a medical oncologist to help me pick one. That's turning into being a bit problematic. I'm now what is considered a "new patient", and probably also considered cancer free, so the appointment dates I'm being given are weeks away. Some of trials require you to start the drugs within a certain number of weeks of having the nephrectomy, so I'm pushing to get my appointment date moved up.
The two most likely candidates are votrient (pazopanib) and afinitor (everolimus). The votrient appears to be slightly more toxic and have more serious side effects, but also appears to be slightly more effective.
Although I'm going to wait until I see the medical oncologist to choose, I'm wondering if anyone here has advice on which one is more likely to be effective? Is it always like that, that the more effective drug also has more side effects and higher toxicity?
Both trials are double-blind studies with a placebo arm. I'm not too excited about possibly being put in a placebo arm and receiving no treatment. On the other hand, if that's a risk I have to take, then I suppose I may go ahead and do it.
I'm having trouble deciding if I should see one of the PI's of the clinical trials for advice, or if I should try and find a medical oncologist that is independent of the trials for advice. I suppose I'm worried the PI's will push their study, but that may be an unfounded concern. Just finding medical oncologists with an interest and experience in RCC has been challenging. I'm lucky in that I live in an area with 3-4 major cancer centers within driving distance, so I should count my blessings. Picking is an issue, and then getting in is the second issue.
I'm very glad I found this board to at least vent some thoughts and feelings (and read other's experiences as well).
Todd
Comments
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Choices
The best decision you could make, in my opinion, is NOT to go into any trial at all. All the indications from research to date are that there are no drugs that prevent recurrence.
You are probably cancer free now and if that is so you're doing no-one any favours entering a trial, least of all yourself your partner and family. Rather get on with your life and if you are unlucky, and have a recurrence, then it may be time to enter a drug trial but as of now there are no grounds for supposing that any drug treatment will affect whether or not you suffer a recurrence.
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trial choiceTexas_wedge said:Choices
The best decision you could make, in my opinion, is NOT to go into any trial at all. All the indications from research to date are that there are no drugs that prevent recurrence.
You are probably cancer free now and if that is so you're doing no-one any favours entering a trial, least of all yourself your partner and family. Rather get on with your life and if you are unlucky, and have a recurrence, then it may be time to enter a drug trial but as of now there are no grounds for supposing that any drug treatment will affect whether or not you suffer a recurrence.
I mostly agree with Tex. Except that when I was offered the votrient trial, it was supposedly to help stop the reoccurance of the disease. So maybe that sounds appropriate. I however did not think that that was what I wanted to do. Thankfully by not choosing to do so, I did get into the MDX trial once my mets were more obvious. I also was not as informed as I am now.
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Doing NothingTexas_wedge said:Choices
The best decision you could make, in my opinion, is NOT to go into any trial at all. All the indications from research to date are that there are no drugs that prevent recurrence.
You are probably cancer free now and if that is so you're doing no-one any favours entering a trial, least of all yourself your partner and family. Rather get on with your life and if you are unlucky, and have a recurrence, then it may be time to enter a drug trial but as of now there are no grounds for supposing that any drug treatment will affect whether or not you suffer a recurrence.
I hadn't really considered that doing nothing was a possibility. Now I've been thinking all day long about that as a real possibility.
I talked to my younger son about it at lunch. I mentioned my uncle had suggested I try to get into a trial. My son said, "Well, that's what doctors do. They want to do something." Sounds simple enough and obvious, but absolutely true.
I'm meeting with the PI of one of the studies on the 14th, but that isn't the only reason to meet him. I'm also considering transfering my follow-up care to that cancer center. In fact, that's the main purpose of my appointment. I'm undecided at this point, but thanks for pointing out the option that I might just wait and do nothing but be followed.
Todd
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Not doing nothing...todd121 said:Doing Nothing
I hadn't really considered that doing nothing was a possibility. Now I've been thinking all day long about that as a real possibility.
I talked to my younger son about it at lunch. I mentioned my uncle had suggested I try to get into a trial. My son said, "Well, that's what doctors do. They want to do something." Sounds simple enough and obvious, but absolutely true.
I'm meeting with the PI of one of the studies on the 14th, but that isn't the only reason to meet him. I'm also considering transfering my follow-up care to that cancer center. In fact, that's the main purpose of my appointment. I'm undecided at this point, but thanks for pointing out the option that I might just wait and do nothing but be followed.
Todd
Remember, you won't be doing nothing, you will be following a proactive set of follow-up tests and scans that would detect a reoccarance (if it ever did come back) very early and you could decide what to do then without worrying about placebo. By then there will most likely be better therapies available than there are today.
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trials
Hi All,
Been sometime since I have posted and I am very happy to see some familar faces. I had to post to give Todd my opinion. I was in your shoes a little less than a year ago. I researched and found they were conducting the everolimus trial in town. After much thought , I decided to go for it. I never wanted to have to look back one day and say what if. My reasoning was that even if I was on the placebo, I would me monitored closely and maybe my participation could eventually help someone else in the future. I just started my 8th cycle, one more to go, finishing 3/20. I see the oncologist every 6 weeks for blood work and have scans every 18 weeks. All I have to do is take 2 pills every morning. I am not sure if I am on the real thing or not as other than some fatigue there have been no side effects. My checkups have been great, last one being yesterday, and scans in December were negative. My final scan for the trial will be after the final cycle in March and then we will discuss the followup protocol. Another plus is that I have established some contacts within the local cancer institue and now I am an established patient with the best oncology group in town. With the experience I have had, I am very grateful I made the decision to enter the trial.
God belss you all,
Wayne
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Newscww71964 said:trials
Hi All,
Been sometime since I have posted and I am very happy to see some familar faces. I had to post to give Todd my opinion. I was in your shoes a little less than a year ago. I researched and found they were conducting the everolimus trial in town. After much thought , I decided to go for it. I never wanted to have to look back one day and say what if. My reasoning was that even if I was on the placebo, I would me monitored closely and maybe my participation could eventually help someone else in the future. I just started my 8th cycle, one more to go, finishing 3/20. I see the oncologist every 6 weeks for blood work and have scans every 18 weeks. All I have to do is take 2 pills every morning. I am not sure if I am on the real thing or not as other than some fatigue there have been no side effects. My checkups have been great, last one being yesterday, and scans in December were negative. My final scan for the trial will be after the final cycle in March and then we will discuss the followup protocol. Another plus is that I have established some contacts within the local cancer institue and now I am an established patient with the best oncology group in town. With the experience I have had, I am very grateful I made the decision to enter the trial.
God belss you all,
Wayne
It's great to hear from you Wayne - I've often wondered how you are and so it's additionally good to learn that you're still doing fine and that the decision you made, after much debate here, was the right one in your particular circumstances.
I'm guessing that you're under snow and that you're more likely to be skiing than golfing!
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snow=no golfTexas_wedge said:News
It's great to hear from you Wayne - I've often wondered how you are and so it's additionally good to learn that you're still doing fine and that the decision you made, after much debate here, was the right one in your particular circumstances.
I'm guessing that you're under snow and that you're more likely to be skiing than golfing!
Hi Tex!
I appreciate you thinking of me, I check the site occasionally to see how everyone is doing but I don't stick around long. We received some snow over Christmas, 4-5 inches, normally that would melt in a few days and courses would be open. However, our high temps have been <30 degrees f so nothing has melted. I awoke this morning to 6 degrees and what Native Americans would call "pogonip" or early western settlers called "white death", aka freezing fog. So, yes I wll be taking to the slopes this weekend for the first time since 2011, as I missed the season last year due to my surgery.
Take care,
Wayne
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Howdy...cww71964 said:snow=no golf
Hi Tex!
I appreciate you thinking of me, I check the site occasionally to see how everyone is doing but I don't stick around long. We received some snow over Christmas, 4-5 inches, normally that would melt in a few days and courses would be open. However, our high temps have been <30 degrees f so nothing has melted. I awoke this morning to 6 degrees and what Native Americans would call "pogonip" or early western settlers called "white death", aka freezing fog. So, yes I wll be taking to the slopes this weekend for the first time since 2011, as I missed the season last year due to my surgery.
Take care,
Wayne
Hey Wayne,
Great to hear you are doing so well and I'm sure your experience will be of great interest to Todd. That's what this site is all about.
Will they tell you after the trial ends if you were on the real deal? I hope you were.
Be careful on the slopes,
Gary
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trialcww71964 said:trials
Hi All,
Been sometime since I have posted and I am very happy to see some familar faces. I had to post to give Todd my opinion. I was in your shoes a little less than a year ago. I researched and found they were conducting the everolimus trial in town. After much thought , I decided to go for it. I never wanted to have to look back one day and say what if. My reasoning was that even if I was on the placebo, I would me monitored closely and maybe my participation could eventually help someone else in the future. I just started my 8th cycle, one more to go, finishing 3/20. I see the oncologist every 6 weeks for blood work and have scans every 18 weeks. All I have to do is take 2 pills every morning. I am not sure if I am on the real thing or not as other than some fatigue there have been no side effects. My checkups have been great, last one being yesterday, and scans in December were negative. My final scan for the trial will be after the final cycle in March and then we will discuss the followup protocol. Another plus is that I have established some contacts within the local cancer institue and now I am an established patient with the best oncology group in town. With the experience I have had, I am very grateful I made the decision to enter the trial.
God belss you all,
Wayne
Hi Wayne.
It just happens that I'm seeing the PI for the same study in a couple of weeks. That wasn't the main point of the visit. I'm looking for a medical oncologist for follow-up and he's very well qualified- much better than anyone at the center I'm at currently. Whether I do the study or not, I'm very likely to move there for my follow up care. The center I'm at was great for my nephrectomy, not so much for medical oncology of kidney cancer.
Will you find out if you were on the placebo at any time? Any chance if you were that they'll give you the drug later?
The frequent scans, are they CT scans without contrast?
I'm curious if they had the Votrien study in your area and whether you considered that one as well?
Thanks so much for posting your experience.
Todd
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trialtodd121 said:trial
Hi Wayne.
It just happens that I'm seeing the PI for the same study in a couple of weeks. That wasn't the main point of the visit. I'm looking for a medical oncologist for follow-up and he's very well qualified- much better than anyone at the center I'm at currently. Whether I do the study or not, I'm very likely to move there for my follow up care. The center I'm at was great for my nephrectomy, not so much for medical oncology of kidney cancer.
Will you find out if you were on the placebo at any time? Any chance if you were that they'll give you the drug later?
The frequent scans, are they CT scans without contrast?
I'm curious if they had the Votrien study in your area and whether you considered that one as well?
Thanks so much for posting your experience.
Todd
Hi All,
I am not sure if they will tell me at the end of the study, I will ask that question. They did tell me that if at some point the study showed positive reults they would unblind it so everyone could get the good stuff.
The ct scans are always with contrast.
Wayne
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I too ‘went for it’ because Icww71964 said:trials
Hi All,
Been sometime since I have posted and I am very happy to see some familar faces. I had to post to give Todd my opinion. I was in your shoes a little less than a year ago. I researched and found they were conducting the everolimus trial in town. After much thought , I decided to go for it. I never wanted to have to look back one day and say what if. My reasoning was that even if I was on the placebo, I would me monitored closely and maybe my participation could eventually help someone else in the future. I just started my 8th cycle, one more to go, finishing 3/20. I see the oncologist every 6 weeks for blood work and have scans every 18 weeks. All I have to do is take 2 pills every morning. I am not sure if I am on the real thing or not as other than some fatigue there have been no side effects. My checkups have been great, last one being yesterday, and scans in December were negative. My final scan for the trial will be after the final cycle in March and then we will discuss the followup protocol. Another plus is that I have established some contacts within the local cancer institue and now I am an established patient with the best oncology group in town. With the experience I have had, I am very grateful I made the decision to enter the trial.
God belss you all,
Wayne
I too ‘went for it’ because I couldn’t bear the thought of looking back and wondering if there was anything else I could have done to prevent recurrence. I’m 4 ½ months into a 36 month study of Sorafenib as adjuvant therapy. I have to admit that I do have days where I wonder if it is all worth it.. the side effects, the emotions, the reduced quality of life. But we’re hanging in there. To be at high risk of recurrence at age 32 just isn’t good enough for me. I too took the view that I would receive closer monitoring throughout (and after) the trial and would become an established patient with oncologists who were willing to support the newest research and trials. I am very grateful to be on the trial. And I’m super grateful to be NVED to date.
I think the best advice is… stay informed. Weigh it all up. Look at how the trial, or no trial, might affect you and your loved ones. These are tough decisions. I wish you all the best. Mel
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Length to take drug?Hanno said:I too ‘went for it’ because I
I too ‘went for it’ because I couldn’t bear the thought of looking back and wondering if there was anything else I could have done to prevent recurrence. I’m 4 ½ months into a 36 month study of Sorafenib as adjuvant therapy. I have to admit that I do have days where I wonder if it is all worth it.. the side effects, the emotions, the reduced quality of life. But we’re hanging in there. To be at high risk of recurrence at age 32 just isn’t good enough for me. I too took the view that I would receive closer monitoring throughout (and after) the trial and would become an established patient with oncologists who were willing to support the newest research and trials. I am very grateful to be on the trial. And I’m super grateful to be NVED to date.
I think the best advice is… stay informed. Weigh it all up. Look at how the trial, or no trial, might affect you and your loved ones. These are tough decisions. I wish you all the best. Mel
Hi Mel,
How long do you have to stay on the drug? I don't think this study is available in my area. So far I've only seen the pazopanib and everolimus.
Do you mind sharing what your tumor stage and grade were? What was the prognosis you were given?
Thanks,
Todd
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The study is called SORCE andtodd121 said:Length to take drug?
Hi Mel,
How long do you have to stay on the drug? I don't think this study is available in my area. So far I've only seen the pazopanib and everolimus.
Do you mind sharing what your tumor stage and grade were? What was the prognosis you were given?
Thanks,
Todd
The study is called SORCE and it's an international phase III trial of sorafenib as adjuvent therapy in intermediate and high risk patients. There are placebo arms involved but there's a 75% chance of receiving the active drug. I think recruiting was due to close last year but is still open. check it out and let me know if u need some links (a bit hard to add at moment on my little phone on the bus).
My tumor was T3a, grade 3 with small areas of grade 2. Clear cell. Removed last June and hanging for next scans in March! cheers, mel
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Oh and the trial runs fortodd121 said:Length to take drug?
Hi Mel,
How long do you have to stay on the drug? I don't think this study is available in my area. So far I've only seen the pazopanib and everolimus.
Do you mind sharing what your tumor stage and grade were? What was the prognosis you were given?
Thanks,
Todd
Oh and the trial runs for three years. Either you take placebo for three years, sorafenib for one year then placebo for two, or sorafenib for three years. i'm in one of the two latter groups. All the best!
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correction: furhman 2 withHanno said:The study is called SORCE and
The study is called SORCE and it's an international phase III trial of sorafenib as adjuvent therapy in intermediate and high risk patients. There are placebo arms involved but there's a 75% chance of receiving the active drug. I think recruiting was due to close last year but is still open. check it out and let me know if u need some links (a bit hard to add at moment on my little phone on the bus).
My tumor was T3a, grade 3 with small areas of grade 2. Clear cell. Removed last June and hanging for next scans in March! cheers, mel
correction: furhman 2 with focal areas of 3.
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TrialHanno said:Oh and the trial runs for
Oh and the trial runs for three years. Either you take placebo for three years, sorafenib for one year then placebo for two, or sorafenib for three years. i'm in one of the two latter groups. All the best!
Thanks for the information. I checked it out, and the trial is closed to new participants. In fact, they have this trial at the same hospital I'm going to be at. 3 years is a long time! I was also T3a, but my Fuhrman grade was 3. The only trials in my area that are still open are pazopanib and everolimus. Both are 1 year and 50/50 placebo. I'm going to do the everolimus trial.
Hope it works for you!
Best,
Todd
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Everolimus Trialcww71964 said:trial
Hi All,
I am not sure if they will tell me at the end of the study, I will ask that question. They did tell me that if at some point the study showed positive reults they would unblind it so everyone could get the good stuff.
The ct scans are always with contrast.
Wayne
I'm starting the same trial you're in next week. So I'm almost 1 year behind you. My doctor said that they would only unblind if I progress or get sick and if I progress after the drug phase is over, he can request to unblind but they may or may not do it.
Glad to hear you're doing well on this trial. Hope that this works.
Thanks for posting. It helps me feel better about the decision I made. My thinking is the same as yours as to why I'm doing it.
Best wishes,
Todd
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