A prospective program aiming at improving outcome for young adults with poor-prognosis non seminomatous germ-cell tumors (VAPOR (GETUG T06))

Trial details

Who runs it

Institut Gustave Roussy

Trial code

EU 2023-505040-19-00

Record updated

2026. február 17.

Original description

The primary objective of this prospective research program that aims at improving outcome for young adults with poor-prognosis 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.Read full original descriptionShow less

The primary objective of this prospective research program that aims at improving outcome for young adults with poor-prognosis 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.

Inclusion: Male patient older than 16 years old on day of signing informed consent; Patient affiliated to social security system or beneficiary of the same; Male must agree to use two methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 6 months after the last treatment intake; Patient with evidence of NSGCT based on histologic examination or based on clinical evidence and elevated serum hCG or AFP levels (in case of clinical emergency, therapy can be started before pathologic sample is obtained if tumor markers are highly elevated); Patient with testicular, retroperitoneal, or mediastinal primary site; Patient with evidence of disseminated disease (clinical stages II or III according to AJCC 8th edition); Patient with disease classified as poor prognosis according to IGCCCG criteria: - Primary mediastinal NSGCT or, - Non-pulmonary visceral metastases or, - hCG > 50 000 UI/L, or AFP > 10 000 ng/mL, or LDH > 10 times the upper normal value; Patient with adequate renal function: measured or calculated (by Cockcroft formula) creatinine clearance > 60 mL/min. Cockcroft formula: CrCl = [(140-age) x weight in kg]/[72 x serum creatinine (mg/dL)]; Patient with absolute granulocyte count  1,500/mm3, platelets  100 000 mm3, bilirubine  1.5x the upper limit of normal value; Patient with a contra-indication of undergoing any brain MRI are eligible, but will not be part of the diagnostic study part; Patient (and his legal guardian for under-18 patient) who had understood, signed and dated the informed consent form.

Exclusion: Patient with prior chemotherapy. Patients who have received a first cycle of cisplatin-base chemotherapy (BEP) for their poor-prognosis NSGCT are eligible as far as tumor marker decline can be assessed at day 18-21; Patient infected by the Human Immunodeficiency Virus (HIV); Patient with previous malignancy, except for basal-cell carcinoma of the skin; Known allergy or hypersensitivity to any of the study drugs; Non inclusion criteria specific to the phase 2 study in patients with unfavorable serum marker decrease and mediastinal primary tumor (to be confirmed before the end of the 1st BEP cycle) 1. Patient (and his legal guardian for under-18 patient) who withdraws his consent 2. Patient with Hepatitis B surface antigen 3. Patient with Hepatitis C antibody 4. Patient with prior high-dose chemotherapy (HDCT) plus hematopoietic stem cell HSCs transplant; Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent.

EU CTIS 2023-505040-19-00