Feasibility of Neo-adjuvant Versus Adjuvant Chemotherapy in Upper Tract Urothelial Carcinoma

Launched by THE EUROPEAN URO-ONCOLOGY GROUP · Nov 17, 2016

Keywords

ClinConnect Summary

This clinical trial is looking into two different chemotherapy treatments for patients with Upper Tract Urothelial Carcinoma (UTUC), a type of cancer that affects the upper urinary tract. The researchers want to see how well these treatments work in real-world settings across various European countries. They will compare the outcomes of patients who receive neo-adjuvant chemotherapy (treatment before surgery) with those who receive adjuvant chemotherapy (treatment after surgery). They are particularly interested in understanding how many patients meet the criteria for these treatments and how those with specific health challenges (like poor kidney function) fare if they only receive standard treatment, which is surgery.

To participate in the trial, patients must be over 18 years old and have a confirmed diagnosis of UTUC. They should not have any other serious cancers or significant health issues that could interfere with their safety. Participants can expect to be part of a carefully monitored treatment plan, with regular check-ups and assessments. This study is currently recruiting participants, and it aims to gather important information that could improve future treatment options for UTUC.

Gender

ALL

Eligibility criteria

• 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 with negative serum pregnancy test within 14 days of first dose of study treatment and agreement to use effective contraception
• • Patients without bladder cancer or with concomitant non muscle invasive bladder cancer
• • Adequate organ system function defined as follows: Hematologic: 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 Upper limit of normal (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 and calcium: within normal limits.
• • CT scan of the chest, abdomen and pelvis and Bone scan without evidence of distant metastasis
• 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.
• • 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
• • Other active neoplasms. Patients with in situ cervical carcinoma, non-melanoma skin cancer or prostate cancer T1 Gleason \<7, Prostate specific antigen (PSA) \<10. Patients with past medical history of cancer can be included if diagnosed at least 4 years ago.
• • Concomitant muscle invasive bladder cancer
• • Patients who have been or still are on methotrexate treatment.