Recruiting

Two chemotherapy approaches for rare aggressive neuroendocrine cancer

Plain-English translation of NCT04325425 on ClinicalTrials.gov ↗ · Source last updated September 2025 · Translation generated July 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing whether a chemotherapy regimen called mFOLFIRINOX works better than the standard treatment (platinum-etoposide) for people with advanced grade 3 neuroendocrine carcinoma. You would be randomly assigned to receive one of these two medication combinations and monitored to see how well it works and what side effects occur.

Grade 3 neuroendocrine cancer is rare and serious, often diagnosed only after it has spread. The current standard treatment helps only some patients, and cancer usually returns within a year. Researchers want to find out if this new medication combination could help more patients live longer and feel better.

Do you qualify?

You likely qualify if…

you have been diagnosed with grade 3 poorly differentiated neuroendocrine cancer that originated in the stomach, intestines, pancreas, or location unknown
your cancer has spread to other parts of your body
you have never received chemotherapy before for metastatic disease
you have at least one measurable tumor that can be seen on imaging scans
you are age 18 or older and in good enough health to tolerate chemotherapy
you have a tumor sample available for testing

You likely don't qualify if…

you have received any prior chemotherapy drugs like carboplatin, cisplatin, oxaliplatin, etoposide, irinotecan, or 5-fluorouracil
you have severe kidney disease or a genetic deficiency affecting how your body breaks down certain chemotherapy drugs
you have pre-existing nerve damage from prior treatments
you have active untreated hepatitis B or C, or HIV infection
you are pregnant, breastfeeding, or unwilling to use effective contraception during and for 15 months after treatment

What participation looks like

You will be randomly assigned to receive one of the two chemotherapy regimens. If assigned to mFOLFIRINOX, you'll receive injections every 2 weeks for up to 12 cycles (about 6 months). If assigned to platinum-etoposide, you'll receive injections every 3 weeks for 6–8 cycles (about 6 months). Throughout treatment, you'll have regular blood tests and imaging scans to monitor how the cancer responds and watch for side effects.

AI-generated summary from trial data · Jul 12, 2026 · Not medical advice

Two chemotherapy approaches for rare aggressive neuroendocrine cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(6 sites)