Upper urinary tract transitional cell carcinoma MedDRA version: 15.0 Level: PT Classification code 10044407 Term: Transitional cell cancer of the renal pelvis and ureter System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Gemcitabine
Pharmaceutical Form: Powder for solution for infusion
INN or Proposed INN: Gemcitabine
CAS Number: 95058-81-4
Concentration unit: mg/ml milligram(s)/millilitre
Concentration
Sponsors
Institute of Cancer Research
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does chemotherapy given around the time of surgery (peri-operative) extend the amount of time for which participants remain free of recurrent disease?;Secondary Objective: - Does peri-operative chemotherapy increase overall survival time? - Does peri-operative chemotherapy extend the amount of time for which participants remain free of widespread (metastatic) disease? - Does peri-operative chemotherapy reduce the occurence of second upper urinary tract or bladder carcinomas? - What are the side effects associated with peri-operative chemotherapy? - How well do participants allocated to chemotherapy adhere to the treatment regimen? - How do peri-operative chemotherapy and surveillance affect participants' quality of life? - What impact do the findings of an embedded qualitative research study into recruitment have on accrual rates and study setup at subsequent sites?;Primary end point(s): The primary outcome measure is disease-free survival (DFS). The main time point of interest is three years after randomisation. DFS is defined as the time from randomisation to the first of: • Death (any cause) • Metastases • Any ureteral or renal bed recurrence (invasive or non-muscle invasive) ;Timepoint(s) of evaluation of this end point: The primary analysis of DFS will be event driven. The primary time-point of interest is 3 years and the Independent Monitoring Committee will advise the Trial Management Group when the primary endpoint should be analysed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Trial feasibility will be assessed continuously during the first two years of recruitment. Acute toxicity will be analysed after all patients have completed 6 months of follow up. All other secondary endpoints will be evaluated after the requirements for analysis of the primary endpoint have been met.;Secondary end point(s): • Trial feasibility, defined by recruitment rate over first two years • Overall survival, defined as the time from randomisation to death from any cause • Recurrence/second primary in the bladder • Contralateral second primary utTCC • Acute toxicity (on-treatment / up to 3 months post-randomisation) • Late toxicity (6 months – 5 years) • Treatment compliance (in the chemotherapy arm) • Metastasis free survival • Quality of life (QoL) as measured by the EORTC QLQ-C30 and EQ5D modules. Domains of interest include Global health/QL, functioning domains and items relating to fatigue and side-effects associated with Gem-Cis/Gem-Carbo. | — |
Countries
Denmark, France, Germany, Italy, Netherlands, Spain, Switzerland, Ukraine, United Kingdom
Contacts
Public ContactRebecca Lewis
Institute of Cancer Research
Outcome results
None listed