Neoadjuvant chemoradiation in locally advanced gall bladder cancer

Prospective study to assess the feasibility of neoadjuvant chemoradiation with concurrent gemcitabine/capecitabine followed by surgery in locally advanced gall bladder cancer and its effect on peripheral immune response and Quality of life

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/03/031918

Enrollment

Registered

2021-03-11

Start date

Unknown

Completion date

Unknown

Last updated

2023-02-06

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

Conditions

Health Condition 1: C23- Malignant neoplasm of gallbladder

Interventions

Intervention1: Neoadjuvant chemoradiation in locally advanced gall bladder cancer: Concurrent chemoradiation with radiation of 50-55 Gy over 25 fractions to gross disease and 45 Gy over 25 fractions t

Eligibility

Inclusion criteria

Inclusion criteria: 1. Histological proven case of gall bladder cancer 2. Locally advanced gall bladder tumors staged as T3/T4, N1/N2 as per the 8th edition of TNM classification of the American Joint Committee on Cancer, with nodes along the common hepatic artery, cystic duct, hepatoduodenal ligament, periportal, peripancreatic and and periduodenal nodes, or T4 tumors that had >2 cm liver invasion. 3. Normal hematological, renal and hepatic functions (serum bilirubin

Exclusion criteria

Exclusion criteria: 1. Age 2. History of prior radiotherapy and chemotherapy 3. H/o prior malignancy 4. Unwilling for written informed consent and follow-up 5. Patients with retroperitoneal nodes 6. Distant metastasis 7. Major medical illness or psychiatric impairment that will prevent completion of protocol or would interfere with follow-up

Design outcomes

Primary

Measure	Time frame
To assess the feasibility of neoadjuvant chemoradiation in locally advanced gall bladder cancer. The primary endpoint is to assess the resectability rate and resection status in patients undergoing neoadjuvant chemoradiation in locally advanced gallbladder cancers. Timepoint: 3 MONTHS	—

Secondary

Measure	Time frame
To assess the local control, toxicity, survival and quality of life Comparison of doses to target volume and organs at risk (OAR) between plans made on breath holding CT and free breathing CT. Analysis of peripheral immune profile (neutrophils, monocytes and lymphocytes), Neutrophil to lymphocyte ratio, platelet to lymphocyte ratio at different intervals (before CRT, 4 weeks after CRT and at 3 months) and their correlation with response to CRT. Timepoint: 3 MONTHS	—

Measure

Time frame

To assess the local control, toxicity, survival and quality of life Comparison of doses to target volume and organs at risk (OAR) between plans made on breath holding CT and free breathing CT. Analysis of peripheral immune profile (neutrophils, monocytes and lymphocytes), Neutrophil to lymphocyte ratio, platelet to lymphocyte ratio at different intervals (before CRT, 4 weeks after CRT and at 3 months) and their correlation with response to CRT. Timepoint: 3 MONTHS

—

Countries

India

Contacts

Public ContactDivya Khosla

Postgraduate Institute of Medical Education and Research

dr_divya_khosla@yahoo.com09876638478

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026