A clinical trial to compare the effects of Adjuvant Chemoradiotherapy versus Adjuvant Chemotherapy in carcinoma gall bladder
- Conditions
- Health Condition 1: C23- Malignant neoplasm of gallbladder
- Registration Number
- CTRI/2023/07/055908
- Lead Sponsor
- All India Institute of Medical Sciences Bhubaneswar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1. Eastern Cooperative Oncology Group (ECOG) Performance Score- 0-1
2. Newly diagnosed, primary gall bladder adenocarcinoma, after radical cholecystectomy with at least one of the following criteria:
i. PT3 or PT4
ii. Lymph node-positive
iii. Margin positive
iv. PT2 with lymphovascular invasion (LVI) or perineural invasion (PNI) or poorly differentiated tumor.
3. Hematological parameters, liver function test, Kidney function test, and cardiac function within normal limits.
1. Inoperable carcinoma gall bladder or with metastasis
2. Previous history of any treatment (chemotherapy, radiotherapy or surgery) for cancer
3. Previous radiotherapy to the abdominal or pelvic region
4. Recurrent gall bladder carcinoma
5. ECOG performance score 2-4
6. Clinically significant cardiac disease and liver dysfunction
7. Pregnant patients
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method