Chemotherapy and Radiotherapy, given either together or sequentially, before surgery followed by surgery in operable cancer of gallbladder patients: A pilot study

Concurrent versus sequential neoadjuvant chemo-radiotherapy followed by surgery in operable carcinoma gallbladder patients: A pilot study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/12/002264

Enrollment

Registered

2011-12-21

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- patients with operable carcinoma of Gall Bladder

Interventions

Intervention1: Gemcitabine, Oxaliplatin, radiotherapy: ARM 1: Weekly GEMOX Day 1, 8, 15 and 22 along with concurrent localized field RT of 35 Gy in 15 Fractions, in 3 weeks, followed by Surgery - exte

Eligibility

Inclusion criteria

Inclusion criteria: a) Subjects with FNAC-proven Gall bladder adenocarcinoma (up to operable stage IVA) which is potentially resectable by preoperative imaging b) Performance status ECOG-1&2 c) Normal renal, hepatic, and hematologic function at the time of enrolment d) Age 18-65 years

Exclusion criteria

Exclusion criteria: a) Patient refusal b) Poor performance status (ECOG â?? 3&4) c) Major co-morbid conditions like cirrhosis, renal failure, uncontrolled hypertension or cardiac failure - d) Subjects who have received chemotherapy within 12 months prior to study entry. e) Prior use of radiotherapy. f) Subjects who have undergone previous surgery on gall bladder/biliary tree. g) Any evidence of metastasis to distant organs (liver, lung, peritoneum). h) Non-contiguous liver metastasis (M1 disease). i) Major vascular involvement such as proper hepatic artery involvement and main portal vein involvement (T4 â?? inoperable disease). j) Periaortic, Pericaval, Superior mesenteric artery and/or Celiac artery lymph node involvement (N2 disease) â?? confirmed by FNAC.

Design outcomes

Primary

Measure	Time frame
Ability to achieve surgical resection Radiological response Timepoint: Ability to achieve surgical resection Radiological response	—

Secondary

Measure	Time frame
Pathological response Toxicity Overall survival (OS) Timepoint: toxicity will be noted during and after chemoradiation, pathological response on histopathological examination of the resected specimen and OS at the end of two years	—

Countries

India

Contacts

Public ContactDr Ameet Kumar

All India Institute of Medical Sciences

peush_sahni@hotmail.com01126594879

Outcome results

None listed

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