RecruitingPhase 2NCT04804007

Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT

Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor


Sponsor

Nabil Adra

Enrollment

64 participants

Start Date

Mar 3, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open label randomized phase II trial of maintenance oral etoposide vs. observation in patinets with relapsed GCT treated with high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether taking a low-dose oral chemotherapy pill (etoposide) after completing high-dose chemotherapy for germ cell tumors (a type of cancer that usually starts in the testicles or ovaries) can prevent the cancer from coming back, compared to just being monitored. **You may be eligible if...** - You are 18 or older - You have non-seminomatous germ cell tumor (a specific type of testicular or ovarian cancer) - Your cancer came back after first-line chemotherapy - You completed high-dose chemotherapy treatment - Your tumor markers and scans show no active disease **You may NOT be eligible if...** - You have active cancer remaining after high-dose chemotherapy - You have severe organ damage from prior treatment - You are unable to take oral medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEtoposide

etoposide will be provided with prescription for etoposide 50mg orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles.


Locations(1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, United States

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NCT04804007


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