NCT05705687

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

A Prospective Program Aiming at Improving Outcome for Young Adults With Poor-prognosis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: Male
• Age: 16 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-05-05
• Primary completion: 2031-02-01
• Completion: 2037-02-01
• First posted: 2023-01-31
• Last updated: 2025-05-08

Locations

1 site across 1 country: France