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

Non-Seminomatous Germ Cell Tumor Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Non-Seminomatous Germ Cell Tumor

• NCT number: NCT05705687
• Study type: Interventional
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Thibault RAOULT, MSc
• Phone: +33 (0)1 42 11 42 11
• Email: thibault.raoult@gustaveroussy.fr
• Status: Recruiting
• Phase: N/A
• Start date: May 5, 2023
• Completion date: February 2037