Exploratory study of feasibility of chemotherapy treatment before and after surgery in upper tract urothelial carcinoma

Phase 1

Conditions: Patients with upper urinary tract transitional cell carcinoma (UTUC)
MedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000017553
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2016-004017-27-NO

Lead Sponsor: European Uro-Oncology Group (EUOG)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 200

Inclusion Criteria

• written informed consent
• Age = 18 years.
• Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract
•Patients with UTUC cT2-pT4 cN0-N1 M0 (TNM classification)
•Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception during the study and for 14 days following the last dose of study treatment.
•Patients without bladder cancer or with concomitant non muscle invasive bladder cancer
•Adequate organ system function defined by Hematological results: Absolute neutrophil count (ANC) ?1.5 X 109/L; Haemoglobin ?5.6 mmol/L ( =9.02g/dL); Platelets ?100 X 109/L; Prothrombin time (PT) or international normalized ratio (INR)b ?1.2 X ULN; Activated partial thromboplastin time (aPTT)?1.2 X ULN. Hepatic: Total bilirubin?1.5 X ULN; Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ?2.5 X ULN. Renal: GRF < or ?55 ml/min: Electrolytes: potassium, magnesium and calcium: within normal limits.
•CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 125

Exclusion Criteria

•Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma.
•History of cardiovascular conditions within the past 6 months.
•Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment.
•Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
•Any major contraindication to a surgical procedure.
•Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
•Active infection contraindicating chemotherapy (under investigator criteria).
•Concomitant diseases that are a formal exclusion to platinum-based chemotherapy (deafness, grade II neuropathy).
•Other active neoplasms. Patients with in situ cervical carcinoma, non-melanoma skin cancer or prostate cancer T1 Gleason <7, PSA <10. Patients with past medical history of cancer can be included if diagnosed at least 5 years ago.
•Concomitant muscle invasive bladder cancer.
•Patients who have been or still are on methotrexate treatment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy;Secondary Objective: To assess 1- and 2-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS) ;Primary end point(s): Proportion of UTUC patients randomized to neo or adjuvant chemotherapy that is actually able to start and finalize three courses of planned chemotherapy<br>;Timepoint(s) of evaluation of this end point: 6 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1- and 2-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS) ;Timepoint(s) of evaluation of this end point: 1,2 and 5 years

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