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clinical trials for stage II pleural - what actually matters when youre picking one

Veteran · · 1,686 views
So I'm six months out from my pleurectomy and my oncologist at the VA keeps bringing up trials. Stage II pleural, good performance status, and apparently I'm a decent candidate for a couple of them. Been doing some digging and there's a lot of noise out there.

Here's what I've figured out matters. First is whether the trial actually fits your stage and cell type. I had epithelioid, which narrows things down compared to sarcomatoid. Second is location. I'm in Norfolk so anything requiring weekly trips to Boston isn't realistic for me, and honestly the travel fatigue can tank your numbers.

Third thing nobody really talks about is what the control arm looks like. Some trials you might get standard chemo, some you might get nothing if you're unlucky. Ask straight up what your odds are of getting the actual experimental treatment versus placebo or standard of care.

Also talk to your medical team about how the trial protocol interacts with your current treatment. I had my surgery in August, and some trials have washout periods where you can't be on certain meds. That matters.

My advice is get the protocol in writing, read it, and ask your doctor to walk you through the endpoints. Not the fancy statistical stuff, the actual outcomes they're measuring. Are they looking at survival, quality of life, side effects, tumor response, what.

I haven't enrolled yet but I'm leaning toward one that's looking at chemo plus immunotherapy for stage II. The center has done a lot of pleural cases and they're transparent about their historical numbers.

Anybody else dealing with trial decisions right now

8 Replies

Attorney Expert Response
Really solid breakdown here, and the point about control arms is one I don't hear enough people raise before they sign consent forms.

From a legal standpoint, the informed consent document is actually a binding agreement, and in most jurisdictions you have the right to withdraw at any point without it affecting your standard care options. Some people don't realize that. The protocol you mentioned getting in writing, that's the document that governs everything, and it may also have implications for any asbestos litigation you're considering or currently pursuing. Some trial participation creates documentation about disease progression and causation that can actually help a case, and occasionally creates complications depending on timing. Worth knowing before you commit.

The washout period issue you flagged matters in litigation too. We had a client in 2019 whose trial enrollment briefly overlapped with a deposition schedule and it created a headache nobody anticipated.

Epithelioid is genuinely the better cell type to be bringing into a trial conversation. Response rates in the checkmate 743 data for epithelioid versus sarcomatoid are dramatically different, so your oncologist's optimism about candidacy probably reflects that.

One thing I'd add from experience sitting in a lot of these conversations with clients and their families, ask specifically whether the trial center has a patient advocate or navigator on staff. Not all of them do, but the ones that do tend to run a much cleaner consent process.

And please do consult an attorney for your specific situation, especially if there's any litigation component to your diagnosis.
4 found this helpful
Veteran
Appreciate you jumping in on this M.S. The consent form thing is exactly what I wish I'd known before digging into all this. My VA coordinator actually walked me through withdrawal rights, but I know a lot of folks don't get that level of detail. You're right that people need to understand they're not locked in forever. That alone makes a difference in how you approach the decision.
Attorney Expert Response
Really solid breakdown, and the control arm point is one most people miss entirely until it's too late to matter.

From the legal side, I've worked with clients who enrolled in trials and later had questions about whether their participation affected their ability to pursue asbestos claims. Short answer is it typically doesn't, but the timing and documentation of your treatment history becomes important. One client had a gap in his medical records from a trial washout period in 2019 that took us several months to reconstruct properly. So if you're also thinking about a legal claim at any point, keep meticulous records of everything, dates, protocols, what you were given and when.

The endpoint question you raised is something I'd push hard on. Overall survival versus progression-free survival are very different things and courts and compensation funds actually look at prognosis documentation closely. A trial measuring tumor response might not generate the kind of survival projections that support a claim the same way one measuring OS would. That's jurisdiction-specific and I'm speaking generally here.

Epithelioid staging at II with good performance status... you're in a window where some of these trials may actually move the needle. The DREAM3R trial data that came out of Australia showed meaningful numbers for that cell type in combination approaches.

Please do consult an attorney familiar with asbestos litigation in Virginia before you enroll, just so you understand how trial participation might interact with any potential claim timeline.
4 found this helpful
Veteran
Got my surgery done in December so I'm a few months behind you but yeah, the trial conversation came up at the VA too. My oncologist at Naval Medical Center San Diego is being real with me about options, which I appreciate.

One thing I'd add is push hard on the washout periods. I'm still on some pain management stuff from recovery and apparently that rules me out of one trial completely. Doesn't matter how good the protocol looks if your current meds disqualify you. Get that answer before you spend time on anything else.

The control arm thing is huge. I asked point blank what happens if I get randomized to standard chemo and they said honestly it could be the same thing I'd get anyway, so worst case I'm not losing ground. Best case I'm in the experimental arm. But you gotta ask that question or you'll wonder about it the whole time.

Location matters more than I thought it would. I'm looking at one trial at Scripps here in San Diego and honestly the fact that I don't have to drive four hours to UCSD or fly somewhere is a real factor. My wife's tired, I'm tired, and every extra thing adds stress that probably doesn't help your body fight this thing.

One more thing from my VA claim experience, make sure whatever trial center you're working with plays nice with the VA system. Some of them do, some don't, and you don't want to get caught in the middle of paperwork hell while you're trying to fight cancer. Ask if they've worked with VA patients before and how they handle the coordination.

I'm leaning toward enrolling but not till I've talked to my oncologist again about those washout periods.
Veteran
Yeah that's exactly it, H. The washout thing bit me too during my initial screening - they almost had me stop a med that was actually helping with my post-op recovery. Caught it in the fine print of the protocol but your doc should be flagging that upfront, not letting you find out the hard way. San Diego's got some solid programs though. You're smart to push back on it now rather than getting enrolled and then hitting a wall.
Veteran
Got my pleurectomy done at Naval Medical Center Portsmouth back in August, so I'm tracking pretty similar to where you're at D. Good thinking on the location piece, that's real. I looked at one trial up in DC and realized real quick that driving 1.5 hours each way every week while recovering wasn't gonna fly. My oncologist at the VA was pushing it too but we found one at Eastern Virginia Medical School that's closer and honestly their track record on pleural cases is solid.

The control arm thing you mentioned is critical. I made sure to ask straight up what I'd actually be getting and what the randomization odds were. Turned out one trial I looked at was 60/40 chance of getting the experimental protocol versus standard chemo, and I wasn't comfortable with those numbers given I already had surgery. Wanted to maximize my shot at something better than what I already know didn't work before the pleurectomy.

One thing that helped me was asking to talk to someone who'd already been through the trial, not just read the promotional material. The VA coordinator made that happen. Guy told me what the actual schedule looked like versus what the protocol said, how the side effects really played out, stuff like that. Made a difference.

I'm enrolled now in the immunotherapy combo you mentioned actually. Started last month. Too early to know if it's working but the process of picking it felt solid. Read the protocol three times, had my doc walk through it with me, and I knew what I was signing up for. That part matters more than people think.
Veteran
Good breakdown there. I went through the same screening back in August right after my pleurectomy and had to make some calls about what made sense.

The location thing is real. I'm here in Norfolk and one trial wanted me at Duke every other week for the first phase. That's an hour and a half each way and honestly after surgery you're not in the headspace for that kind of commute. My VA oncologist, Dr. M., actually pushed back on it for me which I appreciated. Sometimes they see things you don't.

What I didn't expect was how much the protocol details matter for your actual life. I was looking at one that had a contraindication with a blood pressure med I've been on since 2019. Sounds small but that's the kind of thing that gets buried in page 47 of the consent form. You gotta read it or have someone read it with you because the verbal rundown is never complete.

The control arm question is critical. Ask what percentage of people in previous cohorts actually got randomized to the experimental arm versus standard treatment. Some trials the odds are better than others and they won't volunteer that number upfront. I had one doctor finally tell me it was 50-50 and I said thanks but no thanks. If I'm signing up for something new it better have better than a coin flip chance of getting it.

I haven't enrolled either but I'm watching one at VCU that's running chemo plus a checkpoint inhibitor for pleural cases. They've got solid enrollment numbers and the endpoints look reasonable. Haven't committed yet but that's the direction I'm leaning. Takes time to feel confident about it.
Medical Expert Response
What William said about being real with yourself on travel capacity really lands. In my work with mesothelioma patients I've seen people underestimate that piece badly, and there's actually research suggesting that treatment burden on caregivers correlates with patient dropout rates in trials, sometimes as high as 23% in the first two cycles.

One thing nobody's mentioned yet is the psychosocial eligibility criteria. Some trials quietly screen out patients who don't have stable housing or a reliable caregiver, and veterans sometimes fall through that gap. Worth asking the trial coordinator directly, not just the oncologist.

And if you're weighing quality of life endpoints specifically, journaling your symptom patterns for even two weeks before you enroll gives you a real baseline. The Cancer Support Community has a free resource guide on trial participation that I've shared with clients, cancersupportcommunity.org, that covers exactly this. Talk to your own care team about your specific situation of course.
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