A phase III randomised clinical trial of perioperative therapy (neoadjuvant chemotherapy versus chemoradiotherapy) in locally advanced gallbladder cancers (POLCAGB): study protocol
The plan for an Indian trial comparing chemotherapy with chemotherapy plus radiotherapy before surgery for gallbladder cancer that has grown beyond the gallbladder wall.
Overview
Protocol from Tata Memorial Hospital for a randomised trial in biopsy-proven locally advanced (T3 to T4) gallbladder cancer without metastases, comparing gemcitabine-based neoadjuvant chemotherapy with neoadjuvant chemoradiation. The primary endpoint is overall survival; secondary endpoints include progression-free survival, R0 resection rate, toxicity, complications and quality of life. The design targets a 5.5-month improvement in median survival (11 months in the control arm, hazard ratio 0.7) with 80 percent power, requiring 314 patients (157 per arm) over five years with 10 percent attrition. Registered as CTRI/2016/08/007199 and NCT02867865.
- Planned sample 314 (157 per arm) to detect a 5.5-month gain in median overall survival, hazard ratio 0.7, 80 percent power.
- Primary endpoint overall survival; the registry now lists 124 actual participants.
India carries a large share of the world's gallbladder cancer and this is the only randomised test of radiotherapy's role before surgery; the registry's actual enrolment of 124 against a plan of 314 means the answer will be less certain than designed.
- Protocol paper; no results.
- Single-institution design.
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