Maintenance Oral Etoposide After High-Dose Chemotherapy (HDCT) for Patients With Relapsed Metastatic Germ-Cell Tumors (mGCT).
Fadi Taza, Rafat Abonour, Mohammad Abu Zaid...
https://pubmed.ncbi.nlm.nih.gov/36737276Actively Recruiting
Phase 2
Age: 18Years +
All Genders
ID04804007
Randomized Phase 2 Trial of Maintenance Oral Etoposide or Observation Following High-dose Chemotherapy for Relapsed Metastatic Germ-Cell Tumor
Led by Nabil Adra · Updated on 2026-05-08
64
Participants Needed
1
Research Sites
52 weeks
Total Duration
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AI-Summary
What this Trial Is About
Researchers are evaluating maintenance oral etoposide compared to observation after high-dose chemotherapy (HDCT) and peripheral-blood stem-cell transplant (PBSCT) in patients with relapsed germ cell tumor (GCT). This randomized phase II trial aims to understand if maintenance treatment can improve progression-free survival in this population. The study focuses on patients who have completed HDCT and PBSCT within the past 16 weeks and have evidence of relapsed non-seminomatous GCT. Participants will be randomly assigned to one of two groups: maintenance oral etoposide or observation without additional treatment. Those in the etoposide group will take 50 mg of oral etoposide daily for 21 days in each 28-day cycle, repeated for three cycles. Patients assigned to observation will receive no further treatment and move directly to follow-up monitoring. During the study, participants will undergo regular assessments for disease progression and survival for up to 12 months, with additional monitoring of treatment side effects and tolerability for up to two years. Researchers will evaluate tumor markers, organ function, and overall health status. The main outcome measured is progression-free survival at 12 months, with overall survival and safety also assessed. Participants will be followed closely to track any changes in their condition and response to treatment or observation.
CONDITIONS
Brief Title
Maintenance Oral Etoposide or Observation Following High-dose Chemo for GCT
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent and HIPAA authorization for personal health information release
- Age 18 years or older at the time of consent
- Histological or serological evidence of non-seminomatous germ cell tumor
- Relapsed disease after first-line cisplatin-based chemotherapy
- Completed salvage treatment with high-dose chemotherapy and peripheral-blood stem-cell transplant (2 tandem cycles)
- High-dose chemotherapy used as initial salvage regimen (second-line therapy)
- Normal or declining tumor markers (AFP and hCG) at screening
- Adverse events from prior therapy recovered to grade 2 or lower per CTCAE v5.0
- Women with ovarian germ cell tumors eligible
- ECOG performance status of 0, 1, or 2 within 28 days of registration
- Last dose of high-dose chemotherapy within 16 weeks prior to registration
- Adequate organ function lab values within 28 days prior to registration
- Negative urine pregnancy test for women of childbearing potential within 28 days prior to first study drug dose
- Agreement to use two forms of effective contraception or abstain from heterosexual activity during and 30 days after study therapy
You will not qualify if you...
- Relapsed pure seminoma
- Rising tumor markers (AFP and hCG) at screening
- More than 16 weeks since last high-dose chemotherapy dose
- Treatment with any investigational agent within 28 days prior to registration
- Other active malignancy requiring treatment in past 12 months
- History of psychiatric illness or social situations limiting study compliance
- Active infection requiring systemic therapy
- Previous hypersensitivity to etoposide not resolved with care
- Pregnancy, lactation, or breastfeeding
- Any condition, therapy, or lab abnormality that may interfere with study participation or results as judged by investigator
AI-Screening
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Your Study Journey
Screening
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Approximately 12 weeks
Participants randomized to receive maintenance oral etoposide take the drug daily for 21 days out of 28-day cycles, repeated for 3 cycles. Participants randomized to observation do not receive active treatment during this period.
3 cycles with daily oral dosing and periodic visits
Follow-up
Duration - Up to 2 years
Participants are monitored for disease progression, survival, and treatment tolerability after completing treatment or observation.
Regular follow-up visits during this time
Trial Site Locations
Total: 1 location
1
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
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Research Team
C
Christin Snow, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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