Radiation Therapy or Surgery in Treating Patients Receiving Chemotherapy for Bladder Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00867347
First received: March 20, 2009
Last updated: July 9, 2011
Last verified: March 2009
  Purpose

RATIONALE: Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective than surgery in treating patients with bladder cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with surgery in treating patients with bladder cancer who are receiving chemotherapy.


Condition Intervention Phase
Bladder Cancer
Procedure: therapeutic conventional surgery
Radiation: radiation therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Number of patients randomized over 3 years [ Designated as safety issue: No ]
  • Proportion of patients undergoing selective bladder preservation [ Designated as safety issue: No ]
  • Proportion of patients undergoing radical cystectomy [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Compliance with randomized treatment [ Designated as safety issue: No ]
  • Rate of salvage cystectomy after selective bladder preservation [ Designated as safety issue: No ]
  • Toxicity as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]
  • Quality of life as assessed by the QLQ-C30 v3.0 questionnaire [ Designated as safety issue: No ]
  • Locoregional progression-free, metastasis-free, and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 1015
Study Start Date: December 2006
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I

Patients undergo a radical cystectomy, including pelvic lymphadenectomy,

between 4 and 6 weeks after initiating course 4 of chemotherapy.

Procedure: therapeutic conventional surgery
Patients undergo radical cystectomy
Experimental: Arm II
Patients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
Radiation: radiation therapy
Patients undergo radiotherapy

Detailed Description:

OBJECTIVES:

Primary

  • To determine the feasibility and patient acceptability of radical cystectomy vs selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with muscle-invasive transitional cell carcinoma of the bladder.
  • To determine compliance rates of patients with their assigned treatments.
  • To determine if bladder preservation is equivalent to radical cystectomy, in terms of overall survival, in responders to neoadjuvant chemotherapy.

Secondary

  • To compare the overall survival of patients receiving SBP vs radical cystectomy.
  • To determine the rate of salvage cystectomy in patients undergoing bladder preservation.
  • To determine and compare the toxicity of treatment in both arms.
  • To determine and compare quality of life of patients treated with these regimens.
  • To compare locoregional progression-free and metastasis-free survival of patients treated with these regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2, macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment according to randomization arm.

NOTE: *Patients with a clear bladder or those who are unsure of their histological results prior to course 4 also proceed to chemotherapy.

  • Course 4 of neoadjuvant chemotherapy: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 4 hours on day 1.
  • Arm I (radical cystectomy): Patients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
  • Arm II (selective bladder preservation): Patients with no visible residual tumor (cT0 or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.

Health-related quality of life is assessed periodically.

After completion of study treatment, patients are followed periodically for up to 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the bladder

    • Clinical stage T2-T3, N0, M0
  • No widespread carcinoma in situ (CIS) or CIS remote from muscle invasive tumor
  • No adenocarcinoma, squamous cell carcinoma (SCC), small cell carcinoma, or other variant histology

    • N.B. squamoid differentiation or mixed TCC/SCC allowed
  • No simultaneous upper tract, urethral, or prostatic urethral TCC

    • Direct prostatic urethral extension from bladder primary allowed if not involving prostatic stroma
  • Currently receiving 3 courses of gemcitabine hydrochloride-cisplatin or other protocol approved neoadjuvant chemotherapy regimen AND willing and fit to receive a 4th course according to study protocol

PATIENT CHARACTERISTICS:

  • WHO performance status 0-1
  • Hemoglobin > 10 g/dL
  • WBC > 3,000/mm³
  • Platelet count > 150,000/mm³
  • Bilirubin < 1.5 times upper limit of normal (ULN)
  • AST < 1.5 times ULN
  • Alkaline phosphatase < 1.5 times ULN
  • Not pregnant
  • Fit for radical cystectomy or radical radiotherapy
  • No prior malignancy within the past 5 years except superficial TCC or CIS
  • No untreated hydronephrosis

    • Patients with hydronephrosis are eligible if the kidney/ureter has been stented or nephrostomy has been inserted and renal function has been maintained
  • No contraindication to radical radiotherapy (e.g., inflammatory bowel disease, radiosensitivity syndrome, or severe diverticular disease)
  • No bilateral total hip replacements
  • No significant comorbid medical conditions that would interfere with administration of any protocol treatment

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • No prior pelvic radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00867347

Locations
United Kingdom
Institute of Cancer Research - Sutton
Sutton, England, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Investigators
Principal Investigator: Robert A. Huddart, MD Royal Marsden NHS Foundation Trust
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00867347     History of Changes
Other Study ID Numbers: CDR0000633526, ICR-SPARE, ISRCTN61126465, EU-20907, ICR-CTSU/2006/10002
Study First Received: March 20, 2009
Last Updated: July 9, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
transitional cell carcinoma of the bladder
stage II bladder cancer
stage III bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2014