To compare the Overall survival between the patients treated with neoadjuvant chemotherapy alone vs. patients treated with neoadjuvant chemoradiation.

Perioperative therapy (preop chemo v/s CTRT) in locally advanced gall bladder cancers (POLCA-GB)

Status

Active, not recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2016/08/007199

Enrollment

314

Registered

2016-08-17

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Gall Bladder cancer

Interventions

Intervention1: Chemoradiation Arm B: The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300

Eligibility

Inclusion criteria

Inclusion criteria: > 2 cm but Radiological involvement of antropyloric region of stomach, duodenum, hepatic flexure of colon or small intestine, but without infiltration of the mucosa on endoscopy. Type I/II invasion â??Involvement of bile duct (common hepatic duct or proximal 1/3 of the common bile duct) on MRCP/PTBD causing obstructive jaundice Radiological suspicion of lymph node involvement N1 {stations 8, 12, 13) Hepatic artery (Station 8), hepatoduodenal ligament (Station 12), retropancreatic/retroduodenal (Station 13) i.e. size >1cm in short axis, round in shape, and heterogenous enhancement on PET scan. Vascular involvement : impingement/ involvement ( Patient who have undergone prior cholecystectomy having residual disease with at least one of the above features. Biopsy/ FNAC proven adenocarcinoma More than 18 years of age Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 Normal hematological and renal and hepatic functions (serum bilirubin

Exclusion criteria

Exclusion criteria: Resectable disease Evidence of distant metastasis (Liver, Lung, peritoneum, port site etc) Involving major part of the liver precluding restriction of full RT doses Received any prior radiation or chemotherapy.

Design outcomes

Primary

Measure	Time frame
Overall Survival Time interval between the date of randomization and death due to any case.Timepoint: 5 years	—

Secondary

Measure	Time frame
R0 surgical resection rate: Negative surgical margin (R0) rate as determined by intra operative frozen section. However, final confirmation of margin status on histopathology report of the specimen. PFS: Time interval between the date of randomization to loco regional disease progression or death from any cause R1 resection: Microscopic positive margin on histopathology R2 resection: Presence of gross residual disease or tumor spillage during surgery Timepoint: 5 years	—

Measure

Time frame

R0 surgical resection rate: Negative surgical margin (R0) rate as determined by intra operative frozen section. However, final confirmation of margin status on histopathology report of the specimen. PFS: Time interval between the date of randomization to loco regional disease progression or death from any cause R1 resection: Microscopic positive margin on histopathology R2 resection: Presence of gross residual disease or tumor spillage during surgery Timepoint: 5 years

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Countries

India

Contacts

Public ContactMahesh Goel

Tata Memorial Centre

drmaheshgoel@gmail.com9820504492

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 21, 2026