Efficacy study of adding chemotherapy to radiotherapy for treating bladder cancer

Phase 3

Completed

• Conditions: Cancer - Bladder; Transitional Cell Carcinoma of Urinary bladder

• Registration Number: ACTRN12607000041459
• Lead Sponsor: Kumar Gogna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2003-12-22
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Histologically proven Transitional Cell Carcinoma (TCC) of the urinary bladder. Mixed tumours comprising predominantly TCC and elements of squamous or adenomatous metaplasia or carcinoma are also eligible.
2. Clinically and radiologically localised T2, T3 or T4a non-bulky disease (<= 7cm in maximum dimension), N0, M0.If radiological evaluation of a lymph node is interpreted as positive” this must be evaluated further by either lymph node sampling or percutaneous needle biopsy. Patients with histologically confirmed lymph node metastases will not be eligible.
3. Maximal Trans Urethral Resection (TUR). N.B. Previous: a) partial cystectomy; b) endoscopic resection of bladder tumour/s; c) intravesical chemotherapy; or d) intravesical Bacillus Calmette-Guerin (BCG)
does not exclude the patient from being eligible. However, the patient should have an adequate functioning bladder (this should be clarified with the referring Urologist and if need be voiding volumes should be measured).
4. Creatinine clearance >= 50ml/minute by calculation or measurement.
5. A white blood cell count >= 3.5 x 109/L with an absolute neutrophil count >= 1.5 x 109/L and a platelet count >= 100 x 109/L
6. Eastern Cooperative Oncology Group status of 0, 1 or 2.
7. No age limit applies provided the patient is mentally, physically and geographically capable of undergoing treatment and follow-up.
8. No significant intercurrent morbidity.

Exclusion Criteria

1. Pure squamous carcinomas or adenocarcinomas.
2. Extensive or multifocal Carcinoma In Situ (CIS) change in the bladder.
3. T3 or T4a tumours unsuitable for curative treatment (i.e. > 7cm in any dimension), T4b, node positive and metastatic disease.
4. Presence of ureteric obstruction due to tumour infiltration at the Ureteral Orifice (UO) not amenable to stenting.
5. Previous radiation treatment to the pelvis.
6. Previous significant pelvic surgery.
7. Significant bowel or gynaecological inflammatory disease.
8. Creatinine clearance < 50ml/minute by calculation or measurement. A white blood cell count < 3.5 x 109/L with an absolute neutrophil count < 1.5 x 109L and/or a platelet count < 100 x 109/L.
9. Other considerations making patient unfit for Cisplatin therapy.
10. Prior or concurrent malignancy of any other site unless disease-free for greater than 5 years, except for:1. non-melanoma skin cancer, and/or 2. a) Stage T1 well differentiated prostatic carcinoma in men, and b) In situ carcinoma of the cervix in women.
11. Bladder tumour – biopsy only. These patients must be referred back for more adequate resections or else should not be included.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Invasive local failure[At 3 years]

Secondary Outcome Measures

Name	Time	Method
1. Complete response rate[At 3mths from randomisation.];2. Disease free survival.[Time from randomisation to failure or death. Measured until death. ];3. Overall survival.[Time from randomisation to death from any cause. Measured unitl death. ];4. Acute and late toxicity.[Measured every 3 months for the first yr, 6 monthly until 3 yrs and then yearly until death. ];5. Pattern of failure. Local failure, regioanl failure, distant failure and death are anaylsed.[Measured every 3 months for the first yr, 6 monthly until 3 yrs and then yearly until death. ];6. Quality of Life measures.[Measured pre treatment, week 7 at the end of treatment, 3mths, 12 months post treatment and 2 years post treatment.]