Abstract 262TiP
Background
Gallbladder cancer is the commonest malignancy of the biliary tract. The overall 5-year survival rate of gallbladder cancer is poor because of high rates of locoregional and distant failure.There are few retrospective studies showing loco-regional failure as significant as a distant failure. There is no strong evidence in favour of only adjuvant chemotherapy regimens in carcinoma gall bladder. Few retrospective studies are showing the benefit of adjuvant CRT over adjuvant chemotherapy. Locoregional recurrence is higher even after curative resection in the carcinoma gall bladder, particularly if there is T3-4 and/or lymph node-positive disease. Therefore, adjuvant radiation therapy could improve oncology outcomes if patients at high risk for locoregional failure following surgery are selected for radiation therapy.
Trial design
Primary objective To compare the rate of locoregional failure-free survival Secondary objective To compare the following Overall survival Failure-free survival Acute toxicity Quality of life INCLUSION CRITERIA Age- 18-70 years Eastern Cooperative Oncology Group Performance Score- 0-1 Newly diagnosed, primary carcinoma gall bladder including adenocarcinoma, squamous cell carcinoma, Adenosquamous carcinoma, or poorly differentiated carcinoma after radical cholecystectomy with at least one of the following criteria: - PT3 or PT4 - Lymph node-positive - Margin positive - PT2 with lymphovascular invasion (LVI) or perineural invasion (PNI) or poorly differentiated tumor. Hematological parameters, liver function test, Kidney function test, and cardiac function within normal limits EXCLUSION CRITERIA Inoperable carcinoma gall bladder or with metastasis Previous history of any treatment (chemotherapy, radiotherapy or surgery) for cancer Previous radiotherapy to the abdominal or pelvic region Recurrent gall bladder carcinoma ECOG performance score 2-4 Sample Size: 120, 60 in each arm Table: 262TiP
| Randomisation | Control Arm | Experimental Arm |
| Intervention | Adjuvant chemotherapy Patients will receive adjuvant 8 cycles of tablet capecitabine 1000 mg/m2 twice a day for 14 days of a 21days cycle. | Adjuvant chemoradiotherapy Patients will receive concurrent chemoradiotherapy with a total dose of 50.4Gy in 28 fractions in 5 ½ weeks, along with tablet capecitabine 625mg/m2 twice daily. 4 weeks after completion of concurrent chemoradiotherapy, the patients will be started on tablet capecitabine as per control arm for 8 cycles. |
| Follow up | Follow up 3 monthly for first 2 years, 6monthly for next 3 years total upto 5 years | Follow up 3 monthly for first 2 years, 6monthly for next 3 years total upto 5 years |
Clinical trial identification
T/IM-NF/Radio. Onco/22/180, DATE: 31/05/2023, IEC, AIIMS Bhubaneswar, Odisha, India.
Legal entity responsible for the study
D.K. Das.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.