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picking a clinical trial for stage II pleural - what actually matters

Veteran · · 3,091 views
So I'm sitting here waiting for my VA claim to move and my oncologist keeps bringing up trials. I did the surgery in December, feeling decent enough now that maybe I'm supposed to be looking at this stuff. But there's like five different trials they mentioned and I have no idea which one makes sense for where I'm at.

I know stage II is supposed to be better than stage III or IV but I don't know if that changes what trial I should even consider. Like is it just about which hospital is closest or is there actual stuff that matters more.

Anybody else gone through picking one of these. What did you actually look at when you were deciding. Was it the drug they're testing or the location or like how many people had to come in for appointments because I can't do weekly stuff right now, I'm still pretty wiped out.

Also if the trial doesn't work out or I get bad side effects, can you just stop and go back to regular chemo or are you locked in. That's the thing that worries me, like I don't want to waste time on something that's not helping when there's other options.

10 Replies

Veteran
Got my pleurectomy done August of last year, so I'm a few months ahead of where you're at. Still dealing with fatigue too, that part doesn't lie.

Here's what mattered when I was looking at trials. First thing, I asked my oncologist straight up which ones actually had data showing benefit for stage II versus just recruiting bodies. One trial at Eastern Virginia Medical Center wanted me coming in every week for the first month. I nixed that immediately. You know what that does when you're already running on fumes. Another one was every other week but only after the loading phase, that felt more doable.

The drug they're testing does matter, but not in the way you think. It wasn't about which sounded coolest. I looked at what the side effect profile was and whether it overlapped with stuff I already couldn't handle. One had serious lung toxicity risk and I was like, no thanks, already got lung issues. The one I went with had nausea and fatigue listed but nothing that seemed like it would wreck me worse than the surgery already did.

On the locked in question, ask them directly. Most trials I saw had exit clauses if you have serious adverse events or if it's just not working. Not locked in forever, but you do lose some flexibility. That's the trade. You get access to something newer but you're also obligated to follow their protocol.

Location matters more than you'd think because missing appointments tanks the whole thing. I went with the one closer to Norfolk rather than driving to Richmond every time.

What five are they throwing at you?
Attorney Expert Response
The "can you stop" question is one I get more than almost any other, and the answer is almost always yes, you can withdraw consent at any time. That's actually federal law under 21 CFR 50.25, informed consent requirements mandate that trials disclose your right to discontinue without penalty. What people don't always think to ask upfront though is what "stopping" actually looks like practically. Some trials have a washout period before you can start a different therapy, and I've seen that run anywhere from two weeks to sixty days depending on the drug class. So when you're talking to the trial coordinator, I'd ask them specifically: if I withdraw on day 30, what's the earliest I could start something else. Get that in writing if you can.

On the VA claim piece, that's worth a separate conversation. Stage II pleural with documented asbestos exposure may qualify under 38 CFR 3.309 as a presumptive condition depending on your service branch and years of service. The claim and any civil case you might have are separate tracks and one doesn't cancel out the other, but timing can matter.

Consult your own attorney and your oncologist for your specific situation, but those are the two questions I'd want answered before signing anything.
3 found this helpful
Veteran
Did my surgery in August so we're on similar timelines. Here's what I learned going through this same thing at the VA.

First thing, stage II actually does matter for trials. Some of them are specifically looking at earlier stage patients, some want advanced cases. Your oncologist should be telling you which ones you actually qualify for, not just listing five options. I'd push back on that. Ask them to narrow it down to what you're actually eligible for and why.

The location thing is real. I looked at trials at Norfolk Naval Station medical and one down in Durham. Durham was better on paper but it was every two weeks for the first phase, and like you said, I was still dragging. Went with Norfolk even though it wasn't the flashiest protocol. No point being in a trial if you can't actually complete it because you're exhausted from driving around.

Side effects and backing out, that's a legit concern. You're not locked in. I know guys who went three months into something and said this isn't it and stopped. Your oncologist has to support that but it's your call. What matters is you read the informed consent document real careful. Most trials let you withdraw, but some have checkpoints where they don't want you leaving mid-cycle because it messes up their data. That's the stuff buried in the fine print.

What I actually looked at was how often I had to show up, what the actual drug was versus the standard treatment we'd do anyway, and whether they were comparing it to chemo or just testing it straight up. The drug matters more than the location if you're in decent shape to travel a little.

Get them to give you the protocols in writing. Compare the appointment schedules. That's what'll actually affect your life.
Veteran
Yeah that's exactly what I needed to hear. My oncologist's been kinda vague about which ones I actually qualify for, just saying "we have these options." I'm gonna push back at the next appointment and make him spell out the eligibility stuff instead of just listing them all.

The location thing sucks because the closest trial site is still 45 minutes out and I'm not ready for that drive twice a week. Sounds like you dealt with the same issue. Did you end up doing the closer one anyway or did you find one that worked better with your schedule?
Medical Expert Response
These are really good questions and they show you're thinking clearly about this even when you're exhausted, which honestly takes a lot.

The "can I stop" question is one I hear a lot and it matters. Every trial has a withdrawal clause, you can leave at any point for any reason. You're not locked in. The consent form will spell that out specifically, and any oncologist worth their salt will walk you through it line by line before you sign anything.

On the location thing... I worked with a vet in 2019 who was traveling 3 hours each way to a trial at a larger cancer center and by week six it had just ground him down completely. Distance and appointment frequency aren't just logistics, they're clinical factors that affect whether you can actually complete the protocol. So yeah, that matters as much as the drug itself sometimes.

Stage II does open some doors that aren't available to later stage patients, particularly trials testing adjuvant approaches post-surgery. The biomarker profile from your surgical pathology is probably the most important thing to match against eligibility criteria. Things like BAP1 status or PD-L1 expression can determine which arms of a trial you'd even qualify for, so asking your oncologist specifically about your tumor's markers and how they match up with each trial is worth the conversation.

The VA sometimes has navigator services that can help with travel reimbursement for approved trials too. Might be worth a call to your patient advocate there.

If these decisions are feeling heavy and the anxiety is sticking around, talking to an oncology social worker at the cancer center would be a good next step. They can also help with the practical coordination piece.
3 found this helpful
Veteran
Yeah I appreciate that straight answer about the withdrawal thing, that's what I needed to hear. My oncologist kind of glossed over it and I wasn't gonna sign anything without understanding that part. And you're right, the consent forms are pages long so I'll make sure to actually read through instead of just skimming like I usually do with paperwork. The location thing matters more than I thought it sounds like, especially since I'm still recovering and driving to San Diego for appointments every week would just wipe me out worse. Did you work with other vets who had to travel far for trials or did most people end up staying local?
Veteran
Went through this exact thing back in August after my pleurectomy. Had three trials on the table and honestly, the hospital proximity thing mattered way more than I thought it would when I was still running on fumes from recovery.

Here's what I looked at. First was the actual protocol, not just the drug name. Some trials want you in there every week for scans and labs, some are every other week or monthly once you're stabilized. I couldn't do weekly either, still dealing with the surgical recovery and just worn out all the time. Found out one trial at EVMS had a quarterly schedule after month two which made way more sense for where I was at physically.

Second thing was talking to the trial coordinator directly, not just the oncologist. They'll tell you straight up what the time commitment really looks like and what happens if you need to bail. You're not locked in. If side effects get bad or it's not working, you can exit and go back to standard treatment. That was the thing that made me sign on, knowing I had an out if it went sideways.

Stage II might actually help you here because some trials are stratified by stage and they're usually looking for people like you. Better prognosis means better candidate for experimental stuff.

One thing nobody mentioned until I asked directly was the travel. Some trials cover gas or lodging if the hospital's not local. Worth asking about because it adds up fast if you're going to Norfolk or Richmond every month. I ended up staying local and that made the whole thing manageable while still healing up.

Talk to the coordinators. Ask about dropping out. Don't pick based on the drug alone.
Medical Expert Response
These are exactly the right questions to be asking, and the fact that you're thinking this carefully about it matters.

Stage II does change the math here. You're potentially looking at trials that include adjuvant (meaning post-surgery, preventive) immunotherapy or targeted agents rather than the more aggressive combination regimens designed for unresectable disease. The DREAM3R trial and some of the ongoing pembrolizumab adjuvant studies have specifically looked at patients with resectable disease who got surgery first. That's a different population than most mesothelioma trial data historically came from.

On the "can I stop" question, yes, you can withdraw from a clinical trial at any point. That's federal regulation, not optional for the trial team. What gets complicated is timing. Some trials have washout periods (meaning a waiting window before you can start something else) and you'd want to ask exactly how long that is before you sign consent. I've seen patients at Memorial Sloan Kettering in January of last year go through that exact conversation and it changed which trial made sense.

The visit burden question is genuinely important and nobody talks about it enough. Ask for the schedule in writing before you commit. Some trials have weekly PK draws (pharmacokinetic blood samples) for the first two cycles that can be brutal when you're still recovering.

What I'd actually look at in your position: the phase of the trial, whether there's a placebo arm and what percentage gets it, and whether your VA hospital is a participating site because that affects your benefits coordination.

Talk to your oncologist about all of this before deciding, they should be able to pull the actual protocol documents for you.
2 found this helpful
Veteran
Yeah I'd ask your oncologist straight up which trials actually take stage II patients and what the dropout policy is if it's not working, that's the real question. Location matters but not as much as whether you can actually handle the commitment while you're still recovering.
Veteran
Yeah that's what I'm gonna do, pin him down on the dropout stuff because that's been bugging me. The commitment thing is real too - I'm still getting winded walking around the block so weekly appointments in LA or wherever aren't gonna cut it. Thanks for the straight answer, man.

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