Loading clinical trials...
Loading clinical trials...
A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis
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.
Age
16 - No limit years
Sex
MALE
Healthy Volunteers
No
Gustave Roussy
Villejuif, France
Start Date
May 5, 2023
Primary Completion Date
February 1, 2031
Completion Date
February 1, 2037
Last Updated
May 8, 2025
150
ESTIMATED participants
BEP Protocol
DRUG
Dose-dense regimen
DRUG
Early tumor resection or HD-CT
PROCEDURE
Lead Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions