An interventional study of BEP Protocol and Dose-dense regimen in Non-Seminomatous Germ Cell Tumor, sponsored by Gustave Roussy, Cancer Campus, Grand Paris. Recruiting at 1 site in France. Open to male participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-05-08.
Sponsored by Gustave Roussy, Cancer Campus, Grand Paris · Not applicable, Interventional, and Treatment
This is a prospective multicenter, non-randomized research program that includes:
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.
291 studies on the registry are indexed under Neoplasms, Germ Cell and Embryonal; 51 are open to participants now.
This study's planned enrollment of 150 is above the median of 37 across 211 interventional studies indexed under Neoplasms, Germ Cell and Embryonal.
Browse Neoplasms, Germ Cell and Embryonal studies →Gustave Roussy, Cancer Campus, Grand Paris is the lead sponsor of 242 studies on the registry; 65 are open to participants now.
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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)
Exclusion Criteria:
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)
Favorable decline of tumor markers 3 subsequent cycles of protocol BEP every 3 weeks * Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5), * Etoposide 100 mg/m2/day IV x 5 days (D1 to D5) * Bleomycin 30 mg/day IV or IM D1, D8, and D15.
Drug: BEP Protocol
Unfavorable decline of tumor markers, testicular or peritoneal primary tumor 2 cycles every 3 weeks of : * Paclitaxel 175 mg/m2 IV over 3 hours on Day 1, * Cisplatin 20 mg/m2/day IV x 5 days (D1 to D5), * Etoposide 100 mg/m2/day IV x 5 days (D1 to D5) * Bleomycin 30 mg/day IV or IM D1, D8, and D15. * Oxaliplatin 130 mg/m2 IV over 3 hours, given on Day 10, * G-CSF 263 microg/day SC, to be started one day after chemotherapy and stopped one day before the next scheduled chemotherapy cycle (D6-7, D9, D11-14, D16-20). Then, 2 cycles every 3 weeks of : * Cisplatin 100 mg/m2 IV over 2 hours on Day 1, * Bleomycin 25 mg/day, by continuous IV infusion over 24 hours for 5 days from Day 10 to Day 14, * Ifosfamide 2 g/m2 IV over 3 hours on Days 10, 12, and 14, * Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally), * G-CSF 263 microg/day SC on Days 2 to 9 and Days 16 to 20.
Drug: Dose-dense regimen
Unfavorable decline of tumor markers, mediastinal primary tumor, proposal to the patient to enter the phase II part. If patient refusal or ineligible for phase II group, the patient will enter the Unfavorable-dose-dense group. 1 additional cycle of * Paclitaxel 250 mg/m² on Day 1 over the day, * Ifosfamide 1,5 mg/m², * Mesna 500 mg/m2 IV at time-points 0, 3, 7 and 11 hours on the days when ifosfamide is administered (mesna could also be given orally), * Cisplatin 25 mg/m² from Day 1 to Day 5, * Collection of HSC. Then * if no metastases are detectable and the resection is technically feasible : early surgery whenever possible, followed by 2 additional cycles of TIP chemotherapy every 3 weeks * if surgery is not possible or in case of metastatic disease : HDCT (including 3 cycles of the CE regimen (carboplatin AUC 8, using the Calvert formula, from Day 1 to Day 3 and etoposide 400 mg/m² from Day 1 to Day 3)) plus HSC support, followed by surgery of residual deposits.
Procedure: Early tumor resection or HD-CT
anticancer therapy
Also known as: Dose-dense protocol, Early surgery or high-dose chemotherapy
T-BEP-Oxaliplatin followed by Cisplatin - Ifosfamide - Paclitaxel
TIP protocol + early surgery or high-dose chemotherapy if surgery not feasible or metastatic disease
Progression-free survival
Progression-free survival
Time frame: From date of registration until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 108 months after treatment
Plan to share: Undecided
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Gustave Roussy, Cancer Campus, Grand Paris