MedTrace Logo

Comparison of Immediate and Delayed Adjuvant Chemotherapy in Treating Patients Who Have Undergone a Radical Cystectomy for Stage III or Stage IV Transitional Cell Carcinoma of the Bladder Urothelium

NCT00028756 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 285

Last updated 2016-08-02

No results posted yet for this study

Summary

Randomized phase III trial to compare the effectiveness of immediate adjuvant chemotherapy with that of adjuvant chemotherapy given when the cancer returns in treating patients who have undergone a radical cystectomy for stage III or stage IV transitional cell carcinoma of the bladder urothelium. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug and giving them after surgery may kill any remaining tumor cells. It is not yet known if adjuvant chemotherapy is more effective when given immediately after radical cystectomy (surgery to remove the bladder) or when the cancer returns.

Conditions

  • Stage III Bladder Cancer
  • Stage IV Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder

Interventions

DRUG

doxorubicin hydrochloride

Given IV

DRUG

gemcitabine hydrochloride

Given IV

DRUG

vinblastine sulfate

Given IV

DRUG

methotrexate

Given IV

DRUG

cisplatin

Given IV

BIOLOGICAL

filgrastim

Given SC

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Groupe D'Etude des Tumeurs Uro-Genitales

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    collaborator OTHER

  • NCIC Clinical Trials Group

    collaborator NETWORK

  • Arbeitsgemeinschaft Urologische Onkologie

    collaborator OTHER

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Cora Sternberg, Dr. · San Camillo Forlanini Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-10-31
Primary Completion
2014-01-31
Completion
2014-07-31

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00028756 on ClinicalTrials.gov