POLCAGB
An Indian randomised trial asking whether adding radiotherapy to chemotherapy before surgery shrinks locally advanced gallbladder cancer enough to help people live longer.
Overview
POLCAGB, run at Tata Memorial Hospital in Mumbai, randomises biopsy-proven locally advanced (T3 to T4) gallbladder cancer without metastases to gemcitabine-based chemotherapy alone or to chemoradiation, with overall survival as the primary endpoint. The protocol planned 314 patients to detect a 5.5-month gain in median survival (11 months in the control arm, hazard ratio 0.7). The registry lists 124 actual participants, a status of active but not recruiting, an estimated primary completion date of 10 September 2025 and study completion of 10 September 2027. It is registered with the Clinical Trials Registry India as CTRI/2016/08/007199.
Notes
top- Key facts: biopsy-proven locally advanced (T3 to 4) non-metastatic gallbladder cancer; neoadjuvant gemcitabine-based chemotherapy versus chemoradiotherapy before attempted resection with staging laparoscopy and PET-CT; primary endpoint overall survival, powered for 11 versus 16.5 months (hazard ratio 0.7) with 314 planned; 124 enrolled, active but not recruiting, primary completion 10 September 2025. The pilot that motivated it gave response in 77 percent of 26 patients and R0 resection in 46 percent, with biliary leaks in 46 percent tied to the dose to the central hepatobiliary system.
- Enrolment: 124 actual against 314 planned in the protocol paper.
Similar pages
not linked directly; found by shared links- TrialGAIN (AIO/CALGP/ACO)
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
- TrialOPT-IN (EA2197)
Shares Surgery for gallbladder cancer: simple versus radical cholecystectomy, re-resection and lymphadenectomy, Incidental gallbladder cancer (found after cholecystectomy), Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
- Key paperSWOG S0809: A Phase II Intergroup Trial of Adjuvant Capecitabine and Gemcitabine Followed by Radiotherapy and Concurrent Capecitabine in Extrahepatic Cholangiocarcinoma and Gallbladder Carcinoma
Shares SWOG S0809, A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Radiotherapy, Chemoradiation (chemoradiotherapy, CRT) and the tag gallbladder-evidence.
- Key paperNomogram for predicting the benefit of adjuvant chemoradiotherapy for resected gallbladder cancer
Shares A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Radiotherapy, Chemoradiation (chemoradiotherapy, CRT), Neoadjuvant / adjuvant / perioperative and the tag gallbladder-evidence.
- TrialACTICCA-1
Shares Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups) and the tag gallbladder-evidence.
- Key paperValidation of the 8th Edition American Joint Commission on Cancer (AJCC) Gallbladder Cancer Staging System: Prognostic Discrimination and Identification of Key Predictive Factors
Shares A randomised trial of adjuvant chemoradiation after margin-positive or node-positive gallbladder cancer resection, Radiotherapy, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.
- Key paperNeoadjuvant treatment for incidental gallbladder cancer: A systematic review
Shares Incidental gallbladder cancer (found after cholecystectomy), Gemcitabine + cisplatin, Neoadjuvant / adjuvant / perioperative, Gallbladder cancer and the tag gallbladder-evidence.
- Key paperTiming of revision surgery for incidental gallbladder cancer: a systematic review and individual patient data meta-analysis
Shares Incidental gallbladder cancer (found after cholecystectomy), Tata Memorial Centre, Gallbladder cancer roadmap: from a chance finding at gallstone surgery to a disease with its own trials, Gallbladder cancer and the tag gallbladder-evidence.