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

NCT00867347 | Completed Phase 3

• 5 other identifiers: CDR0000633526ICR-SPAREISRCTN61126465EU-20907ICR-CTSU/2006/10002
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder; stage II bladder cancer; stage III bladder cancer

Outcome Measures

Primary Outcomes (4)

• Number of patients randomized over 3 years

• Proportion of patients undergoing selective bladder preservation

• Proportion of patients undergoing radical cystectomy

• Overall survival

Secondary Outcomes (5)

• Compliance with randomized treatment

• Rate of salvage cystectomy after selective bladder preservation

• Toxicity as assessed by NCI CTCAE v3.0

• Quality of life as assessed by the QLQ-C30 v3.0 questionnaire

• Locoregional progression-free, metastasis-free, and overall survival

Study Arms (2)

Arm I

ACTIVE COMPARATOR

Patients undergo a radical cystectomy, including pelvic lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.

Procedure: therapeutic conventional surgery

Arm II

EXPERIMENTAL

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

Interventions

therapeutic conventional surgery PROCEDURE

Patients undergo radical cystectomy

Arm I

radiation therapy RADIATION

Patients undergo radiotherapy

Arm II

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

Study Sites (1)

Institute of Cancer Research - Sutton

Sutton, England, SM2 5PT, United Kingdom

Location

Related Publications (2)

• Paramasivan S, Huddart R, Hall E, Lewis R, Birtle A, Donovan JL. Key issues in recruitment to randomised controlled trials with very different interventions: a qualitative investigation of recruitment to the SPARE trial (CRUK/07/011). Trials. 2011 Mar 15;12:78. doi: 10.1186/1745-6215-12-78.

  PMID: 21406089 RESULT

• Huddart RA, Birtle A, Maynard L, Beresford M, Blazeby J, Donovan J, Kelly JD, Kirkbank T, McLaren DB, Mead G, Moynihan C, Persad R, Scrase C, Lewis R, Hall E. Clinical and patient-reported outcomes of SPARE - a randomised feasibility study of selective bladder preservation versus radical cystectomy. BJU Int. 2017 Nov;120(5):639-650. doi: 10.1111/bju.13900. Epub 2017 May 29.

  PMID: 28453896 RESULT

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Robert A. Huddart, MD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2009
• First Posted: March 23, 2009
• Study Start: July 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: April 1, 2017
• Last Updated: January 4, 2019

Record last verified: 2019-01

Locations

GB (1)