Health Condition 1: N329- Bladder disorder, unspecified Health Condition 2: N33- Bladder disorders in diseases classified elsewhere
Conditions
Interventions
Intervention1: chemotherapy: Patients will be treated for either 3 or 4 cycles of chemotherapy in the neoadjuvant setting. Chemotherapy will be continued in the metastatic setting till the ceiling dos
Sponsors
AIIMS RISHIKESH
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients with histologically confirmed muscle invasive urothelial cancer of bladder. 2. Stage II, III, or IV 3. Age 18 years or older 4. Eastern Cooperative Oncology Group performance status 0, 1, 2 5. Adequate organ and bone marrow function for cisplatin based chemotherapy A. Adequate bone marrow function: Absolute Neutrophil Count (ANC) = 1,500/µL, platelets = 100,000/µL, hemoglobin = 8 g/dL) B. Adequate renal function, Creatinine vlearance using Cockroft Gault formula = 50 ml/min C. Adequate hepatic function: bilirubin D. Adequate cardiac function as decided by clinicalexamination and echocardiogram E. No evidence of hearing loss on clinical examination( Clinical hearing loss to be assessed subsequently by audiometry). 6. Women should use contraceptive medication for 6 months after the end of the study or she would be post-menopause status. Men should consent with the contraception for 6 months after the end of the study or he would be infertile. 7. Patients should sign a written informed consent before study entry.
Exclusion criteria
Exclusion criteria: 1. Histologic types other than urothelial cell carcinoma should be excluded. However, urothelial cell types combined with squamous or glandular features are allowed. 2. Excess of 8 weeks after initial imaging studies. But, allow the patients to enrollment of study if they are reassessed and reconfirm the localized status using subsequent imaging studies. 3. Prior systemic chemotherapy (But prior intravesical chemotherapy is allowed) Neoadjuvant Dose Dense MVAC in MIBC and Locally Advanced Urothelial Carcinoma 4. Peripheral sensory neuropathy grade 2 or worse according to NCI CTCAE version 5. 5. History of treatment with drugs of another clinical trial within 30 days before enrollment. 6. Concomitant severe medical, surgical, or psychiatric disease or problems which can affect the results of the clinical trial or have possibilities of unexpected medical problems caused be the drug of clinical trial A. Unstable angina, myocardial infarction, uncontrolled arrhythmias, symptomatic angina pectoris, cardiac failure within the previous 6 months B. Active infection which would compromise the patients C. Liver cirrohosis or chronic active hepatitis 7. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: defined as the no of patients able to complete 3 or 4 cycles of chemotherapy within the stipulated time. A 10 days lag period will be allowed for those receiving 3 cycles while a 14 days lag period will be allowed for those receiving 4 cycles of chemotherapy to allow the delay due to treatment related toxicities and other administrative delays. Safety: Safety parameters will be assessed as per the Common terminology Criteria for Adverse Events (CTCAE) version 5. 2017 Timepoint: assessment at 38 days for 3 cycles 56 days for 4 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| noneTimepoint: none | — |
Countries
India
Contacts
Public ContactDeepak Sundriyal
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
Outcome results
None listed