Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors
Status:
Not yet recruiting
Trial end date:
2037-02-01
Target enrollment:
Participant gender:
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.