NCT00002566

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not known whether combining chemotherapy with bone marrow transplantation is a more effective treatment for men with germ cell tumors. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with bone marrow transplantation in treating men with relapsed germ cell tumors.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 1994

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1994

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2001

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 15, 2004

Completed
Last Updated

February 23, 2021

Status Verified

February 1, 2021

Enrollment Period

7.8 years

First QC Date

November 1, 1999

Last Update Submit

February 19, 2021

Conditions

Extragonadal Germ Cell TumorTesticular Germ Cell Tumor

Keywords

recurrent malignant testicular germ cell tumorextragonadal germ cell tumor

Interventions

carboplatinDRUG
cisplatinDRUG
cyclophosphamideDRUG
etoposideDRUG
ifosfamideDRUG
vinblastine sulfateDRUG
autologous bone marrow transplantationPROCEDURE
conventional surgeryPROCEDURE
peripheral blood stem cell transplantationPROCEDURE

Eligibility Criteria

Age16 Years - 120 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of testicular or extragonadal male germ cell tumors Must meet 1 of the following conditions after completion of platinum-based first-line chemotherapy: Complete remission (CR) followed by relapse Partial remission (PR) Prior resection of viable malignancy with elevated tumor markers allowed Initial bulky disease with no CR (significantly reduced but still abnormal in plateau) allowed if there is an increase in biological tumor markers or development of new metastases Seminoma with relapse after CR or PR to cisplatin-based chemotherapy allowed No pure seminoma pre-treated with carboplatin No refractory disease (i.e., documented increase in tumor burden and/or serum tumor marker level during or within 1 month after platinum-containing chemotherapy) CNS involvement allowed PATIENT CHARACTERISTICS: Age: 16 and over Sex: Male Performance status: WHO 0-2 OR Karnofsky 50-100% Life expectancy: No limits on life expectancy due to severe non-malignant disease Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No severe cardiac disease that would interfere with study therapy Pulmonary: No severe pulmonary disease that would interfere with study therapy Other: HIV negative No severe neurologic or metabolic disease that would interfere with study therapy No psychological, socioeconomic, or geographic circumstances that would preclude study No other concurrent malignancy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy for metastatic disease allowed Surgery: See Disease Characteristics Prior surgery for metastatic disease allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, F-94805, France

Location

MeSH Terms

Conditions

Testicular Germ Cell TumorTesticular Neoplasms

Interventions

CarboplatinCisplatinCyclophosphamideEtoposideIfosfamideVinblastinePeripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesEndocrine System DiseasesTesticular DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsChlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsPhosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsPhosphoramidesOrganophosphorus CompoundsPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesOxazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsVinca AlkaloidsSecologanin Tryptamine AlkaloidsIndole AlkaloidsAlkaloidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingIndolizidinesIndolizinesHematopoietic Stem Cell TransplantationStem Cell TransplantationCell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Jose-Louis Pico, MD

    Gustave Roussy, Cancer Campus, Grand Paris

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

January 15, 2004

Study Start

February 1, 1994

Primary Completion

December 1, 2001

Study Completion

December 1, 2003

Last Updated

February 23, 2021

Record last verified: 2021-02

Locations

FR(1)