MedTrace Logo

Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors

NCT05705687 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-05-08

No results posted yet for this study

Summary

This is a prospective multicenter, non-randomized research program that includes:

* a phase IV study (for all patients) with a collection of tissue specimens of tumor,
* a phase II study (for patients with primary mediastinal tumors and an unfavorable decline in tumor markers),
* and a diagnostic study (for all patients, except patients with brain metastases at baseline or patients for whom any brain MRI is contra-indicated).

The main question it aims to answer is improving outcome for young adults with poor-prognosis Non Seminomatous Germ Cell Tumor (NSGCT) is to validate prospectively the efficacy and safety of a personalized treatment based on early tumor marker kinetic assessment in real life for patients with poor-prognosis NSGCT.

Participants will be followed-up according to the assessment of decline kinetics of the tumor markers at the end of a first chemotherapy cycle and according to the localisation of the primary lesion if unfavorable.

* In the case of a patient with a favorable decline of the tumor markers, he will be treated by 3 additional standard chemotherapy cycles.
* In the case of a patient with a testicular or peritoneal primary tumor and an unfavorable decline of the tumor markers, the patient will be treated by a dose-dense standard therapy.
* The patient with a mediastinal primary tumor and an unfavorable decline of the tumor markers will be proposed to enter the phase II part of the study or to enter the dose-dense regimen like the other primary localisations. If the patient consents and is eligible for phase II part, he will undergo either an early surgery if feasible or a high-dose chemotherapy if the early surgery is not possible.

Conditions

  • Non-Seminomatous Germ Cell Tumor

Interventions

DRUG

BEP Protocol

anticancer therapy

DRUG

Dose-dense regimen

T-BEP-Oxaliplatin followed by Cisplatin - Ifosfamide - Paclitaxel

PROCEDURE

Early tumor resection or HD-CT

TIP protocol + early surgery or high-dose chemotherapy if surgery not feasible or metastatic disease

Sponsors & Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-05
Primary Completion
2031-02-28
Completion
2037-02-28

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705687 on ClinicalTrials.gov