A clinical trial to compare the effects of Adjuvant Chemoradiotherapy versus Adjuvant Chemotherapy in carcinoma gall bladder

Comparison of Adjuvant Chemoradiotherapy versus Adjuvant Chemotherapy in carcinoma gall bladder- A phase III randomized controlled study - CRT-GB

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055908

Enrollment

120

Registered

2023-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2023-08-21

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: Adjuvant Chemoradiotherapy: Patients will receive concurrent chemoradiotherapy with a total dose of 50.4Gy in 28 fractions in 5 Â½ weeks, 1.8Gy per fraction along with tablet capecitabi

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
To compare the rate of locoregional failure-free survival (LRFFS) between adjuvant chemoradiotherapy versus adjuvant chemotherapy in the curatively resected carcinoma gall bladder.Timepoint: To compare the rate of locoregional failure-free survival (LRFFS) between adjuvant chemoradiotherapy versus adjuvant chemotherapy in the curatively resected carcinoma gall bladder at 5 years	—

Secondary

Measure	Time frame
To compare the following parameters across both the arms throughout the follow-up period a. Overall survival (OS) b. Failure-free survival c. Acute toxicity d. Quality of life Timepoint: At 5 years	—

Countries

India

Contacts

Public ContactDr Deepak Kumar Das

All India Institute of Medical Sciences Bhubaneswar

deepak.scb2006@gmail.com9478552547

Outcome results

None listed

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