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Gall Bladder Cancer (GBC) commonly presents in locally advanced or metastatic stage. First-line CT is the standard of care and those who progress and are unresectable are administered second line chemotherapy on disease progression. We are conducting a randomised study of consolidationChemoradiation(CTRT) vs observation in responders to first line CT (NCT05493956). This is based on the improvement in overall survival with consolidation CTRT in departmental database of 140 LA- GBC patients (in press, JGO, 2019,vol 5, suppl, 97). The primary endpoint is overall survival. We are reporting the toxicity due to CTRT.

Responders to first line CT (gemcitabine and cisplatin) will be randomised to CTRT vs observation after 4 cycles. The primary end point of the study is to compare OS between the two arms. The secondary end point is to compare progression free survival (PFS), acute and late toxicity, and quality of life between the two study arms. The trial is designed to detect an improvement in 2-year OS from 8% in the control arm to 25% in study arm with 80.0% power at a 0.05 significance level. The resultant sample to achieve this aim is 140 (70 in each arm) over a duration of 4-5 years with a 10% attrition rate. CTRT will be delivered by 3DCRT along-with concurrent capecitabine @1250 mg/m2.The total target dose of RT was 45Gy in 25 fractions to GBC and lymphatics followed by a boost of 9 Gy in 5 fractions to the GBC. Toxicities documented during CTRT were recorded using the CTCAE version 3.0. Dose volume data of Liver, Stomach, Duodenum and Kidney were correlated with the radiation induced side effects. After completion of treatment patients were followed up and assessed clinically every month and CT scan abdomen 3 monthly until disease progression

A total of 132 patients have been enrolled. Median age of presentation is 53 years (IQR), of which 63% are females. 58% patients had T4 tumours and 42% had N2 and 27% underwent upfront stenting for obstructive jaundice. Both arms are well balanced demographically. Due to CTRT, 20% had grade 1 nausea, 20%, 14% and 9%, had anaemia (grade1,2,3), 30% grade 1 dyspepsia, 6% patients experienced GI bleed (3% grade 4), 16% patients’ hepatic dysfunction (gr 1). 9% patients could not complete RT mainly due to hepatic dysfunction (n=5), Covid (n=1). Dose volume corelation of side-effects will be presented in the meeting

These observations suggest that consolidation CTRT is tolerable.