cancer in urinary upper tract urethelial carcinoma
Conditions
Interventions
Surgery is standard patient care
Chemotherapy in patients with bladder and upper tract rinary carcinoma is often
also considered standard of patient care.
Thus, no true intervention within the contex
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract Patients with UTUC cT2-cT4 cN0-N1 M0 (TNM classification) Patients without bladder cancer or with concomitant non muscle invasive bladder cancer. Adequate organ system function CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis
Exclusion criteria
Exclusion criteria: Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma. Any major contraindication to a surgical procedure. Other active neoplasms. Concomitant muscle invasive bladder cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of UTUC patients with adequate renal function that were able to receive either neo- or adjuvant cisplatin-based chemotherapy treatment Proportion of UTUC patients randomized to neo- or adjuvant chemotherapy that were able to start and finalize three courses of planned chemotherapy Actually delivered dose vesus planned dose of chemotherapy administered in patients randomized to neo- or adjuvant chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- and 2-year Disease Free Survival (DFS), Overall Survival (OS) and Cancer-Specific Survival (CSS) Safety and tolerability of neo-adjuvant versus adjuvant chemotherapy Evaluate histopathology in each group and histological response in the neo-adjuvant patient group | — |
Countries
Netherlands
Outcome results
None listed