Response evaluation of muscle-invasive bladder cancer treated with radiotherapy and chemotherapy with Cisplatin or Gemcitabine

Phase 2

Recruiting

• Conditions: Transitional Cell Carcinoma of bladder.; Malignant neoplasm of bladder

• Registration Number: IRCT2017040332913N2
• Lead Sponsor: Vice-Chancellor for Research of Iran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Primary carcinoma of the bladder (Transitional Cell Cancer) with
muscularis propria invasion diagnosed within 8 weeks of registration; clinical stage T2-T4a, Nx or N0, M0 without hydronephrosis; the patient can tolerate systemic chemotherapy combined with pelvic radiotherapy and a radical cystectomy by joint agreement of the Urologist and Oncologist; The following laboratory tests that has been done within 4 weeks prior to registration on this study is as following: WBC greater than or equal to 4000, ANC greater than or equal to 1800, Hemoglobin greater than or equal to 10.0, Platelets greater than or equal to 100,000, Creatinine clearance greater than or equal to 60ml/min, Serum creatinine of 1.5 or less, If no, the creatinine clearance is greater than 60 ml/min and serum creatinine is no more than 1.8 Serum bilirubin of less than or equal to 2.0 mg%; No evidence of distant metastases, The patient has not received prior pelvic radiation therapy or chemotherapy, nor had cancers other than non-melanoma skin cancer and early stage cancer of prostate or cervix; the patient has none of any of the severe, active co-morbidities defined as following: Unstable angina and/or congestive heart failure, requiring hospitalization within the last 6 months, transmural myocardial infarction within the last 6 months, acute bacterial or
fungal infection requiring intravenous antibiotics at the time of registration, chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration; hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; acquired immune deficiency syndrome (AIDS) based upon current CDC definition; The patient has no known severe sensitivity reactions to the drugs used in the trial.

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response to treatment. Timepoint: seven to eight weeks after initiation of induction treatment. Method of measurement: Cystoscopy biopsy and pathological review.

Secondary Outcome Measures

Name	Time	Method
Disease Free Survival. Timepoint: Every 3 months for 2 years. Method of measurement: Follow-up with history, physical examination, scans and urine and blood tests.