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picking a clinical trial for pleural meso stage 2 - what actually matters

Veteran · · 40 views
So I'm six weeks out from my pleurectomy and my oncologist at Eastern Virginia Medical Center is talking clinical trials. Says there's a couple options for stage 2 pleural and I'm trying to figure out which one makes sense instead of just saying yeah to the first thing they mention.

From what I can tell there's trials running right now for different approaches. Some are looking at combining chemo with other stuff, some are the ttfields thing everyone keeps asking about. My doc said the trial selection depends on what stage you are and what your scan looks like and whether you can actually get to the appointments.

I was hull technician on the Oriskany for twenty years so I'm used to reading specs and understanding systems. I figure clinical trials probably have specs too but I don't know what questions to ask. Like does it matter if the trial is at a big center versus a smaller hospital. Does it matter if it's been running for two years versus six months. What's the difference between a phase 2 and phase 3 trial besides the number.

Anybody here actually in a trial right now or made this decision already. What did you look at that actually mattered versus what turned out to be noise.

8 Replies

Veteran
Been through the trial selection process myself a couple months back. Ask your doc straight up what the enrollment numbers are and how many patients have actually completed it, not just started it. That tells you more than how long it's been running.
Family
My dad's oncologist at Northwestern ran through similar options with us back in April, right after his diagnosis. He ended up not qualifying for the trials we looked at because of his baseline pulmonary function, but going through that process taught me a lot about what actually moves the needle versus what sounds impressive.

The phase 2 versus phase 3 thing matters more than you'd think. Phase 2 is still proving the drug works and figuring out dosing, so there's more variability in outcomes and more frequent monitoring. Phase 3 is comparing it head to head against standard treatment, which is closer to what your actual prognosis would look like. Your oncologist will probably recommend based on what stage you are and what the data's showing, but honestly the biggest thing we looked at was the protocol itself. Some trials require scans every two weeks, some every month. Some require you to be within driving distance for visits, some are set up so your local oncologist can handle the between-visit stuff. That matters way more than whether it's at a big name center or not. A smaller hospital running a well-designed trial is better than a prestigious place running something that's poorly organized.

TTFields is its own thing. It's not chemo, it's electrical stimulation, and it's actually FDA approved now for meso so you don't necessarily need a trial for it. The trials running now are mostly looking at combining it with chemo to see if that's better than either one alone.

What nobody really talks about is asking them straight up what the dropout rate is. If 40% of people don't finish the trial, that tells you something about the burden or the side effects. We asked that question and it completely changed how my dad felt about one option.

Your technician background actually helps here. Ask to see the actual protocol document, not just the summary. Read through the exclusion criteria yourself. Sometimes there's stuff buried in there that would disqualify you and you want to know that upfront instead of getting invested.
Veteran
Got my pleurectomy done at EVMC back in August so we're pretty close in the timeline. This is solid thinking on your part, C.

Phase difference matters more than people realize. Phase 2 is still figuring out if the drug even works and what the side effects look like. Phase 3 is comparing it against the standard treatment to see if it's actually better. You want Phase 3 if it's available. That's where you get real data. Phase 2 you're basically helping them learn.

Location and appointment schedule are not noise. I'm not gonna sugarcoat it, treatment is a grind. We drive down to Portsmouth for my follow-ups and it's eating up days. If you're looking at a trial that wants you there every week and it's an hour away versus 15 minutes, that's the difference between you being able to stick with it and burning out halfway through. I've heard from guys on the forums who had to drop out because the logistics just weren't working.

How long the trial has been running, yeah that matters some. Six months in they're still working out the protocol, dealing with supply issues, all that. Two years in at least you know they can keep the lights on. Ask them how many patients they've enrolled so far and how many they still need. That tells you if they're desperate or if they actually have a solid program.

The specs approach is good. Get the actual protocol document and read it. What's the dosage schedule. What are the exclusion criteria. Are you disqualifying yourself for something without knowing it. We're used to understanding systems, use that.
Medical ✓ Expert Response
Six weeks post-pleurectomy and already doing this level of research... that kind of mindset genuinely helps people get through this process well.

So the phase question is real and it matters. Phase 2 is still figuring out "does this work and is it safe," Phase 3 is comparing it against the current standard of care with a much larger group. For stage 2 pleural specifically, a Phase 3 trial often means you have a 50/50 chance of getting the experimental arm versus what they'd give you anyway, which some people find reassuring and others find frustrating. Worth asking your oncologist exactly what the control arm looks like.

The thing I've seen matter most in 12 years of this work, honestly, is the trial coordinator. Not the lead investigator, not the institution's ranking. The coordinator is who calls you back, who explains the consent form at 7pm when you're panicking, who catches a scheduling conflict before it becomes a protocol violation. I've watched people at major academic centers get lost because the coordinator was stretched thin, and I've watched people at smaller sites get exceptional support. Ask to speak with the coordinator before you enroll, like actually have a 10 minute conversation with them.

On the logistics piece, the appointment burden is real and it's something people underestimate. Some trials require bloodwork every two weeks, some require scans every six, some have windows that are strict enough that missing an appointment by 48 hours can remove you from the study. The informed consent document, which they're required to give you, will list every required visit. That document is your spec sheet.

If you want to look at what's currently enrolling, clinicaltrials.gov lets you filter by condition, stage, and distance from your zip code. A second opinion at a mesothelioma specialty center is also worth considering, places like Brigham and Women's or Baylor see enough volume that they sometimes know about trials that aren't widely publicized yet.

And if the weight of all this decision-making starts feeling like too much, that's a completely normal response to an enormous amount of pressure. Talking with an oncology social worker at your center, or even a counselor who works specifically with cancer patients, can help you sort through what you're feeling alongside what you're deciding.
3 found this helpful
Veteran
Yeah that phase breakdown makes sense, sounds like phase 3 is basically them proving it works versus just making sure it doesn't kill you. The 50/50 thing though, that's what I need to think through. My doc mentioned one trial where you could get randomized into standard chemo or the combo approach, and I'm trying to figure if I'd be okay with that or if I should push for something where I know what I'm getting. Did you see patients who had a preference on that, or does it come down to how confident they feel about the standard option anyway?
Medical ✓ Expert Response
One thing nobody's mentioned yet that I see trip people up constantly: the exclusion criteria buried in section 4 of most trial protocols. Things like prior anticoagulation therapy, specific kidney function thresholds (GFR below 45 is a common cutoff), even certain cardiac history. I had a patient last spring who'd done everything right, got excited about a promising phase 2 combining pemetrexed with a checkpoint inhibitor, and got screened out in week one because of a statin interaction nobody flagged ahead of time.

So before you fall in love with any particular trial, ask your EVMC team to pull the full protocol document and go through the exclusion list together, not just the summary on clinicaltrials.gov. The summary is basically marketing. The protocol is the actual specs, which sounds like exactly what you're used to reading.

And on the "big center vs smaller hospital" question... the MARS2 trial data actually showed that surgical expertise and post-op management consistency mattered more than institution size for outcomes. It's about who's done this specific procedure how many times, which your team at EVMC should be able to tell you honestly. Talk to your oncologist about your specific numbers before reading too much into any general comparison.
3 found this helpful
Medical ✓ Expert Response
Dr. Chen's point about exclusion criteria is so real, and I'd add something that doesn't always come up in these conversations: the emotional and logistical weight of the trial schedule itself.

I worked with a patient at Sentara last spring who qualified beautifully on paper for a promising phase 3 trial. But the protocol required visits every 14 days for the first six months. He lived 90 minutes out. By week eight he was exhausted in a way that had nothing to do with treatment side effects, and he withdrew.

Your hull technician background actually gives you a real advantage here. Ask for the actual protocol document, not the summary sheet. Look at the visit schedule the same way you'd read a maintenance spec, total number of required visits, what happens if you miss one, whether there are remote monitoring options built in. Some trials have that flexibility now and some absolutely don't.

The psychosocial load of a trial is something oncology teams sometimes underestimate when they're presenting options. A journal can help you track not just symptoms but how the schedule is actually hitting you week to week, which becomes useful data for your care team too.
2 found this helpful
Veteran
Yeah that's the part that actually matters. My wife and I mapped out the drive to EVMC for my own appointments and 0600 starts twice a week would've killed me during recovery. I wasn't thinking straight enough to be driving that far anyway. So when my doc mentioned the trial options I asked first thing which ones don't require weekly visits. Turns out one of them is monthly checkups after the initial phase. That changed everything for me. Logistics aren't noise, R. They're the whole ballgame.

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