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

Impact of neoadjuvant chemotherapy on organ preservation in muscle invasive urinary bladder carcinoma

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/08/009318
Enrollment
20
Registered
2017-08-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- healthy

Interventions

Intervention1: chemotherapy, radiotherapy, surgery: 20 patients were planned to be enrolled in this study from april 2014-October 2015. All patients were treated with 3cycles of Neoadjuvant chemother

Sponsors

NONE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Muscle invasive bladder carcinoma, 2. Stage T2-T4, N0- N1,M0according to AJCC 2010 Staging. 3. Karnofsky Performance Status scale(KPS) >70. 4. All patients were explained about the protocol and a written informed consent was obtained.

Exclusion criteria

Exclusion criteria: 1. Non muscle invasive bladder carcinoma / Metastatic disease. 2. KPS 3. Significant comorbid conditions like Hypertension, Diabetes Mellitus, Coronary artery disease for more than 5 years. 4. Any other primary malignancy 5. Abnormal Haemogram: a. Haemoglobin 6. Abnormal renal function test: a. Blood urea >50mg/dl, b. Serum creatinine >1.2mg/dl.

Design outcomes

Primary

MeasureTime frame
1.To assess the response rate after neoadjuvant chemotherapy. 2.To assess the response rate after radical radiation therapy. Timepoint: 6 weeks

Secondary

MeasureTime frame
.To evaluate treatment related toxicitiesTimepoint: 3 months

Countries

India

Contacts

Public ContactDr Chinna Babu D

POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH (PGIMER)

drnarendra74@gmail.com7087009393

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026