Actively Recruiting
Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors
Led by Gustave Roussy, Cancer Campus, Grand Paris · Updated on 2025-05-08
150
Participants Needed
1
Research Sites
717 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Validation of a Treatment Algorithm for Poor-Risk NSGCTnon Seminomatous Germ-cell Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patient older than 16 years old on day of signing informed consent
- Patient with evidence of NSGCT based on histologic examination or clinical evidence with elevated serum hCG or AFP levels
- Patient with primary tumor located in testicular, retroperitoneal, or mediastinal sites
- Patient with disseminated disease (clinical stages II or III according to AJCC 8th edition)
- Patient with disease classified as poor prognosis according to IGCCCG criteria including primary mediastinal NSGCT, non-pulmonary visceral metastases, or high tumor marker levels (hCG > 50,000 UI/L, AFP > 10,000 ng/mL, or LDH > 10 times normal)
- Patient with adequate renal function (creatinine clearance > 60 mL/min)
- Patient with absolute granulocyte count ≥ 1,500/mm³, platelets ≥ 100,000/mm³, bilirubin ≤ 1.5 times upper normal limit
- Patient eligible for brain MRI or with contraindication for brain MRI (not included in diagnostic study if contraindicated)
- Patient who has understood and signed informed consent
- Patient affiliated with social security or equivalent
- Male of child-bearing potential agreeing to use two forms of contraception during study and 6 months after
- For phase II study: patient with mediastinal primary tumor and unfavorable serum marker decline after first chemotherapy cycle who has signed specific consent
You will not qualify if you...
- Patient infected with Human Immunodeficiency Virus (HIV)
- Patient under legal guardianship or deprived of liberty or incapable of consent
- Patient with prior chemotherapy except one cycle of cisplatin-based BEP if tumor marker decline can be assessed
- Patient with previous malignancy except basal-cell carcinoma of the skin
- Known allergy or hypersensitivity to study drugs
- For phase II study: patient who withdraws consent
- Patient with Human T-cell Leukemia Virus (HTLV) type 1 or 2
- Patient positive for Hepatitis B surface antigen
- Patient positive for Hepatitis C antibody
- Patient with prior high-dose chemotherapy plus hematopoietic stem cell transplant
AI-Screening
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Trial Site Locations
Total: 1 location
1
Gustave Roussy
Villejuif, France, 94800
Actively Recruiting
Research Team
E
Elodie LECERF, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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