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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Nabil Adra
Study ID
NCT04804007
Phase
PHASE2
Status
Recruiting
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Conditions

  • Germ Cell Tumor
  • Non-seminomatous Germ Cell Tumor
  • Ovarian Germ Cell Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etoposide — DRUG
    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.

Study Details

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).

Key Dates

Start date
Mar 3, 2021
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maintenance Oral Etoposide
    Maintenance daily oral Etoposide.
  • No Intervention: Observation
    If randomized to Observation, subjects will jump to follow-up.

Primary Outcome Measure

12-month Progression Free Survival [ Time Frame: time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana University Melvin & Bren Simon Cancer CenterIndianapolisIndiana46202
Christin Snow, RN
[email protected]
317-274-5830
Nabil Adra, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Indiana University Melvin & Bren Simon Cancer Center· Indianapolis, IN

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