Gall Bladder Carcinoma
Conditions
Keywords
gallbladder, locally advanced, neoadjuvant
Brief summary
to study role of chemotherapy treatment for gall bladder cancer before surgery as compared to surgery directly
Detailed description
Gallbladder cancer is a highly aggressive disease with a late presentation and poor prognosis. Complete surgical excision remains the only potentially curative treatment for early-stage gallbladder cancer. The use and benefit of chemotherapy in gallbladder cancer before surgery , that is , in the neoadjuvant setting, is not well studied and, to our knowledge, neoadjuvant chemotherapy has not been evaluated in any randomized clinical trial. Neoadjuvant chemotherapy aims to achieve tumor downstaging, increase the radical surgical resection rate, reduce metastases. This study will compare the effectiveness of chemotherapy before surgery in locally advanced gall bladder cancer versus upfront surgery with respect to survival and completeness of resection of disease.
Interventions
DRUGneoadjuvant chemotherapy
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. PAtients will undergo curative surgery after neoadjuvant chemotherapy
PROCEDUREcurative surgery
Patient being taken up for 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
Sponsors
Rajiv Gandhi Cancer Institute & Research Center, India
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
1. Early GBC ( cT1/T2) without significant lymphadenopathy or liver infiltration on radiological imaging . 2. Locally advanced disease requiring major hepatectomy or whipple's pancreatoduodenectomy. 3. Post cholecystectomy GBC without any evidence of spillage of residual disease on radiological imaging. 4. Obstructive jaundice due to involvement of biliary tree by tumour. 5. Vascular involvement such as common hepatic artery, MPV right hepatic artery or right portal vein. 6. Any distant metastasis or isolated port site metastasis 7. Involvement of non-regional LN (e.g . Celiac LN, SMA lymph node, inter-aortocaval or left para-ortic LN). 8. Poor performance status ECOG 3 or more. 9. Pregnancy. 10. Inability or unwillingness to follow study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| improvement in 3 year overall survival | 3 year | To compare the 3 year overall survival with Neoadjuvant chemotherapy and surgery versus upfront surgery in locally advanced resectable gall bladder cancer |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post operative outcomes | 90 days | To compare mortality and morbidity rate in two groups |
Countries
India
Contacts
Primary ContactShivendra Singh, Mch
Backup ContactShaifali Goel, DrNB
Outcome results
None listed