Neoadjuvant Chemotherapy Versus Upfront Surgery for Locally Advanced Resectable Gall Bladder Cancer : A Randomized Trial

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• ECOG 0-2

• Locally advanced resectable GBC defined as Clinical T3/4 disease or Regional LN involvement on imaging studies.

• Post cholecystectomy GBC with residual disease on imaging, History of bile spillage during primary surgery , history of piece-meal removal of gall bladder during simple cholecystectomy, Regional LN involvement on imaging studies.

Locations
Other Locations
India
Rajiv Gandhi Cancer Institute and Research Centre
RECRUITING
Delhi
Rajiv Gandhi Cancer Institute and Research Centre
RECRUITING
Delhi
Rajiv Gandhi Cancer Institute and Research Centre
RECRUITING
Delhi
Contact Information
Primary
Shivendra Singh, Mch
shiven_24@yahoo.co.in
+919818975024
Backup
Shaifali Goel, DrNB
doctor.shaifali@gmail.com
+918368382060
Time Frame
Start Date: 2025-01-01
Estimated Completion Date: 2028-12
Participants
Target number of participants: 114
Treatments
Experimental: upfront surgery
after staging workup and biopsy, patient being taken up for upfront surgical exploration will undergo staging laparoscopy followed by exploration and interaortocaval lymphnode sampling. After ruling out distant metastasis, local resectability will be reassessed and curative surgery will be performed. . Post-operative complications were recorded and graded according Clavien Dindo classification
Experimental: Neoadjuvant chemotherapy followed by surgery
NACT group will receive gemcitabine and platinum combination. Most common regimen comprised of gemcitabine (1000 mg/ m2 intravenously over 30-60 min) on days 1 and 8, and cisplatin (75 mg/ m2 intravenously over 2 h) on day 1, every 21 days. In case of renal compromise, carboplatin was used. Response was assessed using CECT abdomen and PET scan. Chemotherapy related toxicity will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v 5 .0.
Sponsors
Leads: Rajiv Gandhi Cancer Institute & Research Center, India

This content was sourced from clinicaltrials.gov