Squamous cell carcinoma of the bladder Cancer Bladder cancer
Conditions
Interventions
At UK secondary care NHS Trusts all patients received three 21-day cycles of CMV chemotherapy (cisplatin 100 mg/m2 given on day 2, methotrexate at 30 mg/m2 and vinblastine at 4 mg/m2, both given intra
Sponsors
Medical Research Council
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pure squamous cell carcinoma of the urinary tract in one of the following groups: 1.1. initial presentation with T3-T4 disease 1.2. pelvic relapse after radiotherapy or surgery 1.3. nodal or metastatic disease 2. At least one site of disease assessable for response by clinical examination or imaging. One or more of the sites below can be used to assess response: 2.1. primary bladder tumour (satisfactory measurements of the primary tumour if present and measureable, must have been made by bimanual examination after transurethral resection (TUR)) 2.2. other primary tumours in the urinary tract (satisfactory measurements of the primary tumour in the urinary tract, if present and measureable, must have been made by clinical examination or appropriate imaging) 2.3. pelvic relapse after radiotherapy or surgery (at least one indicator lesion must be measurable by clinical examination or appropriate imaging) 2.4. nodal or metastatic disease (at least one indicator lesion must be measurable by clinical examination or appropriate imaging. NB: Bone metastases cannot be used as an indicator lesion. 3. Calculated glomerular filtration rate (GFR), calculated by the method of Cockcroft and Gault (1976) >50 ml/min. In patients with impaired renal function secondary to ureteric obstruction this may be relieved by ureteric stents or nephrostomies, and if the renal function then recovers the patient will be eligible. 4. White blood cell count >3.5 x 10(9)/l and platelet count >100 x 10(9)/l 5. No previous systemic treatment with chemotherapy 6. No concomitant or previous malignancy other than basal cell carcinoma of skin or carcinoma in-situ of the cervix 7. Fit to tolerate CMV
Exclusion criteria
Exclusion criteria: 1. Transitional cell carcinoma with squamous metaplasia, or other mixed tumours 2. Co-existing illness (e.g. cardiac failure) that may compromise administration of CMV chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study was overall response at 9 weeks (or post-chemotherapy if chemotherapy was stopped) after the commencement of the treatment (i.e. end of 3 cycles). Definition of response was assessed by the treating clinician as follows: Complete response (CR): The disappearance of all known malignant disease. If the initial primary tumour was in the bladder, and cystectomy has not been performed, an assessment should be made of this primary tumour. If the response of the primary bladder tumour is classified as complete response (CR) on bimanual examination and cystoscopy, a deep resection biopsy should be performed at the site of the original tumour and recorded as biopsy positive or negative, i.e: CR(B-) Complete response on cystoscopic and bimanual examination. Biopsy negative. CR(B+) Complete response on cystoscopic and bimanual examination. Biopsy positive. CR(Bo) Complete response on cystoscopic and bimanual examination. Biopsy not done. Partial response (PR) : At least 50% reduction of the sum of the products of the two largest perpendicular diameters of all lesions measured at registration. In addition there can be no appearance of new lesions nor progression of any lesion. No change (NC): Less than 50% reduction of the sum of the products of the two largest perpendicular diameters of all lesions measured at registration and no lesion measured at registration has shown a 25% increase in size. Progressive disease: A 25% or more increase in the size of one or more lesions measured at registration, or the appearance of new lesions. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Treatment compliance 2. Safety 3. All-cause mortality 4. Time to all-cause death These were recorded by NHS staff at the treating hospitals on Case Report Forms (CRF) at the time points of the completion of chemotherapy, first follow-up at 6 months, subsequent 6-monthly follow-ups or death. Overall survival was calculated as the time from the date of registration to date of death or censored at the time last seen if still alive. | — |
Countries
England, Norway, Poland, Scotland, United Kingdom
Outcome results
None listed