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Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer

Primary Purpose

Bladder Cancer

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
cisplatin
fluorouracil
radiation therapy
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder

Eligibility Criteria

undefined - 75 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institut Bergonie
  • CHR de Grenoble - La Tronche
  • Dr. Bernard Verbeeten Instituut

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 1, 1999
Last Updated
March 5, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00003642
Brief Title
Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer
Official Title
A Phase II Feasibility Study of Combined Accelerated External Radiation and Chemotherapy With 5FU and CDDP Following Transurethral Resection in Patients With Muscle Invasive Transitional Carcinoma of the Bladder - T2-T3, N0, M0 (UICC 1992)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
October 1998 (undefined)
Primary Completion Date
July 2001 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: I. Evaluate the rate of severe acute toxicity occurring during therapy with accelerated external radiotherapy with concurrent fluorouracil (5-FU) and cisplatin following transurethral resection of the bladder in patients with stage II or III muscle invasive transitional cell carcinoma of the bladder. II. Evaluate the rate of freedom from local recurrence to this combined therapy assessed 3 months after the end of treatment in these patients. III. Assess the feasibility of this new therapeutic approach in this patient population. IV. Determine the overall recurrent free survival, long term side effects, and overall survival in these patients. OUTLINE: This is an open label, multicenter study. Patients undergo accelerated external radiotherapy twice daily 5 days a week for 5 weeks. Concurrent chemotherapy is administered on the first and fifth week consisting of cisplatin IV over 2 hours daily and fluorouracil by 24 hour continuous infusion daily on days 1-5. Patients are followed at 3 months, then every 3 months for the first 2 years, and then every 6 months thereafter. PROJECTED ACCRUAL: There will be 19-43 patients accrued into this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
stage II bladder cancer, stage III bladder cancer, transitional cell carcinoma of the bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
43 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michel Bolla, MD
Organizational Affiliation
CHU de Grenoble - Hopital de la Tronche
Official's Role
Study Chair
Facility Information:
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHR de Grenoble - La Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Dr. Bernard Verbeeten Instituut
City
Tilburg
ZIP/Postal Code
5042 SB
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
18568488
Citation
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.
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Radiation Therapy and Chemotherapy Following Surgery in Treating Patients With Stage II or Stage III Bladder Cancer

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