NCT00003642

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. 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 combining radiation therapy with chemotherapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of radiation therapy combined with fluorouracil and cisplatin in treating patients who have stage II or stage III bladder cancer, and who have undergone transurethral resection.

Trial Health

40
At Risk

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Geographic Reach
2 countries

3 active sites

Status
terminated

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

October 1, 1998

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
2.8 years until next milestone

First Posted

Study publicly available on registry

April 9, 2004

Completed
Last Updated

March 6, 2012

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

November 1, 1999

Last Update Submit

March 5, 2012

Conditions

Bladder Cancer

Keywords

stage II bladder cancerstage III bladder cancertransitional cell carcinoma of the bladder

Interventions

cisplatinDRUG
fluorouracilDRUG
radiation therapyRADIATION

Eligibility Criteria

AgeUp to 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed unifocal or multifocal transitional cell carcinoma of the bladder no greater than 5 cm, with evidence of muscle invasion documented by transurethral resection of the bladder (TURB), with no residual visible or palpable tumor mass at the end of TURB Stage II or III (T2-T3, N0, M0) No squamous cell or adenocarcinoma No evidence of pelvic lymph node involvement by CT scan or MRI No evidence of hydronephrosis No evidence of distant metastases No disease in the prostatic urethra PATIENT CHARACTERISTICS: Age: Under 76 Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 11 g/dL Hepatic: Not specified Renal: See Disease Characteristics Creatinine clearance greater than 50 mL/min Cardiovascular: No progressive ischemic cardiopathy Other: No reduced bladder capacity No prior or concurrent malignancy except basal cell carcinoma or carcinoma in situ of the cervix treated by hysterectomy PRIOR CONCURRENT THERAPY: Biologic therapy: Prior immunotherapy for superficial disease allowed No concurrent growth factors Chemotherapy: No prior systemic chemotherapy Prior intravesical chemotherapy or intravesical BCG allowed Endocrine therapy: Not specified Radiotherapy: No prior pelvic radiotherapy Surgery: No prior surgery for bladder cancer except transurethral resection of the bladder

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

Sponsors & Collaborators

Study Sites (3)

Institut Bergonie

Bordeaux, 33076, France

Location

CHR de Grenoble - La Tronche

Grenoble, 38043, France

Location

Dr. Bernard Verbeeten Instituut

Tilburg, 5042 SB, Netherlands

Location

Related Publications (1)

  • Poortmans PM, Richaud P, Collette L, Ho Goey S, Pierart M, Van Der Hulst M, Bolla M; EORTC Radiation Oncology Group. Results of the phase II EORTC 22971 trial evaluating combined accelerated external radiation and chemotherapy with 5FU and cisplatin in patients with muscle invasive transitional cell carcinoma of the bladder. Acta Oncol. 2008;47(5):937-40. doi: 10.1080/02841860801888799.

    PMID: 18568488RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

CisplatinFluorouracilRadiotherapy

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrinary Bladder DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum CompoundsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTherapeutics

Study Officials

  • Michel Bolla, MD

    CHU de Grenoble - Hopital de la Tronche

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 9, 2004

Study Start

October 1, 1998

Primary Completion

July 1, 2001

Last Updated

March 6, 2012

Record last verified: 2012-03

Locations

NL(1)FR(2)