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A study of the effects and side effects of chemotherapy and radiotherapy in a post operated case of gall bladder cancer.

A Prospective Study of Efficacy and Toxicity of Adjuvant Chemo-radiation in Resected Gall Bladder Cancer - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057198
Enrollment
40
Registered
2023-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: Chemo-radiation: All patients will receive adjuvant or perioperative chemotherapy for 6 cycles every 21 days as follows- Gemcitabine at a dose of 1000 mg/m2 on day 1 & 8 and oxaliplatin

Sponsors

Institute of Medical Sciences, Banaras Hindu University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Histologically proven post operative gall bladder carcinoma, T2 and above stage and/or node positive disease, ECOG of 0-1, Adequate hematological, renal and hepatic function, Adequate creatinine clearance.

Exclusion criteria

Exclusion criteria: History of previous cancer or radiotherapy, Second synchronous malignancy, Any contraindication for concurrent chemo radiation.

Design outcomes

Primary

MeasureTime frame
Loco regional control Acute toxicityTimepoint: 3 & 6 months

Secondary

MeasureTime frame
Overall survival Disease free survival Late toxicityTimepoint: DFS & OS at 3 and 6 months Late toxicity after 3 months

Countries

India

Contacts

Public ContactDr Pamela Sen

Institute of Medical Sciences, Banaras Hindu University

ritushamishra@yahoo.co.in7376748436

Outcome results

None listed

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