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The plan for an Indian trial comparing chemotherapy with chemotherapy plus radiotherapy before surgery for gallbladder cancer that has grown beyond the gallbladder wall.
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.
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.
Shares POLCAGB, Tata Memorial Centre, Chemoradiation (chemoradiotherapy, CRT), Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
Shares Chemoradiation (chemoradiotherapy, CRT), Neoadjuvant / adjuvant / perioperative, Gallbladder cancer and the tag gallbladder-evidence.
Shares Tata Memorial Centre, Gallbladder cancer and the tag gallbladder-evidence.
Shares Tata Memorial Centre, Gallbladder cancer and the tag gallbladder-evidence.
Shares Neoadjuvant / adjuvant / perioperative, Gallbladder cancer and the tag gallbladder-evidence.
Shares Neoadjuvant / adjuvant / perioperative, Gallbladder cancer and the tag gallbladder-evidence.
Shares Chemoradiation (chemoradiotherapy, CRT), Gallbladder cancer and the tag gallbladder-evidence.
Shares Gallbladder cancer and the tag gallbladder-evidence.