3-Dimensional Conformal Radiation Therapy in Treating Patients With Bladder Cancer Who Have Undergone Transurethral Resection of the Bladder

NCT01124682 | Unknown Phase 1

• 5 other identifiers: CDR0000671670ICR-IDEALEU-21035CCR-3217MREC-09/H0801/40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. PURPOSE: This phase I trial is studying the side effects and best dose of 3-dimensional conformal radiation therapy in treating patients with bladder cancer who have undergone transurethral resection of the bladder.

Conditions

Bladder Cancer

Keywords

adenocarcinoma of the bladder; squamous cell carcinoma of the bladder; transitional cell carcinoma of the bladder; recurrent bladder cancer; stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

• Maximum-tolerated dose

Secondary Outcomes (8)

• Progression-free survival

• Overall survival

• Bladder preservation rates

• Acute and late toxicity and safety profile

• Quality of life

Interventions

diagnostic cystoscopy PROCEDURE

diffusion-weighted magnetic resonance imaging PROCEDURE

implanted fiducial-based imaging PROCEDURE

quality-of-life assessment PROCEDURE

3-dimensional conformal radiation therapy RADIATION

image-guided radiation therapy RADIATION

selective external radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed invasive bladder carcinoma, including the following cellular types: * Adenocarcinoma * Transitional cell carcinoma * Squamous cell carcinoma * Clinical stage G1-3, pT2a-4 disease * Localized disease * No bone or visceral metastases * No lymph node metastases * Has undergone maximal transurethral resection of the bladder tumor and planning to receive radical radiotherapy PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Hemoglobin \> 10 g/dL * WBC \> 3,000/mm\^3 * Platelet count \> 150,000/mm\^3 * Creatinine \< 120 μmol/L * Bilirubin \< 1.5 times upper limit normal (ULN) * AST \< 1.5 times ULN * Alkaline phosphatase \< 1.5 times ULN * Not pregnant * No inflammatory bowel disease or other significant small bowel disease * Physically fit for radical radiotherapy * No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * No other malignancy within the past 2 years except adequately treated basal cell carcinoma of the skin or adequately treated carcinoma in situ of the cervix uteri * Prior superficial transitional cell carcinoma of the bladder allowed PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior pelvic surgery * No bilateral hip replacements compromising accurate radiotherapy planning * No prior radiotherapy to the pelvis

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)

Royal Marsden - Surrey

Sutton, England, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Radiotherapy, Conformal; Radiotherapy, Image-Guided; Serotonin Plasma Membrane Transport Proteins

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)

Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics; Symporters; Ion Pumps; Membrane Transport Proteins; Carrier Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plasma Membrane Neurotransmitter Transport Proteins; Neurotransmitter Transport Proteins; Solute Carrier Proteins; Membrane Proteins

Study Officials

• Robert A. Huddart, MD

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 14, 2010
• First Posted: May 17, 2010
• Study Start: May 1, 2009
• Primary Completion: April 1, 2016
• Last Updated: August 26, 2013

Record last verified: 2011-02

Locations

GB (1)