Chemotherapy followed by radiotherapy response assessment in muscle invasive urinary bladder carcinoma

Phase 2

Completed

• Conditions: healthy

• Registration Number: CTRI/2017/08/009318

Brief Summary

Conservativeapproaches in muscle invasive bladder carcinoma (MIBC) evolved recently withthe aim of avoiding surgery which may have a negative impact on the quality oflife. The non-surgical treatment has been traditionally reserved for patientswho are unfit for, or refuse radical cystectomy. But there is growing evidencethat, availability of new chemotherapeutic protocols and radiotherapy  techniques  have made bladder  preservation a competitive alternative tocystectomy in selected patients.

Atotal 20 patients with urothelial carcinoma of urinary bladder of stage T2-T4, N0- N1,M0 (AJCC 2010) who were fit for combined radiochemotherapy andrefused radical surgery were selected and enrolled. All patients were treated with three cycles of NACT.

AfterNACT, 18 patients (90%) who had partial response (PR) >50% , receivedradical radiation, and two patients (10%) who had PR <50%, underwent radicalcystectomy. All patients who received radiation showed complete response, sixweeks after RT. After median follow up of 26 months, 2 patients developed local recurrence, underwent salvagecystectomy. One patient developed local and distant failure. Hematologic and non hematologic toxicities wereacceptable.

Conservative treatment in MIBC patients with NACT followed by RT providesa high probability of local response with acceptable toxicity in properlyselected patients.Our trial shows that organ preservation is a valid option in early stages ofMIBC

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-25
• Study Completion: 2015-10-30
• Last Update Posted: 2017-09-08

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Muscle invasive bladder carcinoma, 2.
• Stage T2-T4, N0- N1,M0according to AJCC 2010 Staging.
• Karnofsky Performance Status scale(KPS)>70.
• All patients were explained about the protocol and a written informed consent was obtained.

Exclusion Criteria

• Non muscle invasive bladder carcinoma / Metastatic disease.
• Significant comorbid conditions like Hypertension, Diabetes Mellitus, Coronary artery disease for more than 5 years.
• Any other primary malignancy 5.
• Abnormal Haemogram: a.
• Haemoglobin < 10gm/dl, b.
• Platelet count< 100000/ cmm, c.
• Total leucocyte count < 3000/cmm.
• Abnormal renal function test: a.
• Blood urea >50mg/dl, b.
• Serum creatinine >1.2mg/dl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2.To assess the response rate after radical radiation therapy.	6 weeks
1.To assess the response rate after neoadjuvant chemotherapy.	6 weeks

Secondary Outcome Measures

Name	Time	Method
.To evaluate treatment related toxicities	3 months

Trial Locations

Locations (1)

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER); 🇮🇳 Chandigarh, CHANDIGARH, India

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)

🇮🇳Chandigarh, CHANDIGARH, India

Dr Chinna babu D

Principal investigator

9855803437

chinnababudraksham@gmail.com