Chemotherapy following surgery or close follow up in upper tract urothelial cancer

• Conditions: pper urinary tract transitional cell carcinoma; MedDRA version: 15.0Level: PTClassification code 10044407Term: Transitional cell cancer of the renal pelvis and ureterSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002577-33-GB
• Lead Sponsor: Institute of Cancer Research

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-09
• Last Update Posted: 25 September 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

1.Written informed consent
2.=18 years of age
3.Post radical nephroureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/SCC is permitted.
4.Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). Patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected).
5.Satisfactory haematological profile (ANC> 1.5 x 109/L, platelet count 100 x 10/L ) and liver function tests (bilirubin < 1.5 x ULN, AST and Alkaline phosphatase < 2.5 x ULN), Glomerular filtration rate = 30 mls/min.
6.Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
7.WHO performance status 0-1.
8.Available for long-term follow-up
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 145
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

1.Evidence of distant metastases
2.Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
3.Un-resected macroscopic nodal disease
4.Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
5.GFR <30 mls/minute. NB Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin ie for GFR 30-49mls/min. Patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial
6.Significant co-morbid conditions that would interfere with administration of protocol treatment
7.Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
8.Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified