Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

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

Lead Sponsor:

UNICANCER

Conditions:

Extragonadal Germ Cell Tumor

Teratoma

Eligibility:

All Genders

16-120 years

Phase:

PHASE3

Brief 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 ch...

Detailed Description

OBJECTIVES: * Compare progression-free survival rates of patients with poor prognosis stage II or III non-seminomatous germ cell tumors with an unfavorable decrease of tumor markers after treatment w...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    November 26 2003

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    February 8 2023

    Estimated Enrollment :

    263 Patients enrolled

    Trial Details

    Trial ID

    NCT00104676

    Start Date

    November 26 2003

    End Date

    February 8 2023

    Last Update

    February 6 2025

    Active Locations (24)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 6 (24 locations)

    1

    M. D. Anderson Cancer Center at University of Texas

    Houston, Texas, United States, 77030-4009

    2

    Centre Paul Papin

    Angers, France, 49100

    3

    Institut Bergonie

    Bordeaux, France, 33076

    4

    C.H.U. de Brest

    Brest, France, 29609