CompletedPhase 3

Combination Chemotherapy in Treating Patients With Stage II or Stage III Germ Cell Tumors

United States, France263 participantsStarted 2003-11-26

Plain-language summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This randomized phase III trial is comparing two different combination chemotherapy regimens to see how well they work in treating patients with stage II or stage III non-seminomatous germ cell tumors.

Who can participate

Age range16 Years – 120 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

DISEASE CHARACTERISTICS: * Diagnosis of non-seminomatous germ cell tumors (NSGCT) as evidenced by 1 of the following criteria: * Histologically confirmed NSGCT * Clinical evidence of disease AND high serum human chorionic gonadotropin (HCG) or alpha-fetoprotein (AFP) levels * Clinical stage II-III disease (disseminated disease) * Testicular, retroperitoneal, or mediastinal primary site * Poor prognosis disease, meeting 1 of the following criteria: * Mediastinal primary site * Non-pulmonary visceral metastases * One of the following lab values: * HCG \> 50,000 UI/L * AFP \> 10,000 ng/mL * Lactate dehydrogenase \> 10 times upper limit of normal (ULN) PATIENT CHARACTERISTICS: Age * Over 16 Performance status * Not specified Life expectancy * Not specified Hematopoietic * Absolute granulocyte count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin ≤ 1.5 times ULN Renal * Creatinine clearance \> 60 mL/min Other * No other prior malignancy except basal cell skin cancer * No HIV positivity PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior chemotherapy Endocrine therapy * Not specified Radiotherapy * Not specified Surgery * Not specified

What they're measuring

Progression-free Survival Rate After 1 Course of Treatment

Timeframe: 3 years from randomization

Trial details

NCT IDNCT00104676

SponsorUNICANCER

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-03-29

Results submitted2021-02-18