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

ConditionsGerm Cell TumorNon-seminomatous Germ Cell TumorOvarian Germ Cell Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNabil Adra

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent and HIPAA authorization for release of personal health information

Age ≥ 18 years at the time of consent

Histological or serological evidence of non-seminomatous GCT

Relapsed disease after first-line cisplatin-based combination chemotherapy

Disqualifiers

Relapsed pure seminoma

Rising tumor markers (AFP and hCG) at time of screening

Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) >16 weeks ago

Treatment with any investigational agent within 28 days prior to study registration

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Maintenance Oral EtoposideExperimental treatment 1 intervention
Group B: ObservationNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

12-month Progression Free Survival

Investigator determination of tumor progression (clinical, radiographic, tumor markers including AFP and hCG)

Time frame
time from the date of randomization to the date of disease relapse or death (i.e. up to 1 year)

Secondary outcomes

1

12-month Overall Survival

Time frame
Time of registration to death from any cause (i.e. up to 1 year)
2

Assess toxicity and tolerability of maintenance etoposide

Toxicities according to CTCAE v5 will be summarized by frequencies and rates calculated as the proportion of patients in the safety population experiencing SAEs, discontinuations due to AEs, and AEs.

Time frame
through study completion (i.e. up to 2 years)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nabil Adra

Lead sponsor

Indiana University

Sponsor institution

Source ClinicalTrials.gov
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