Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Neoadjuvant chemotherapy: Neoadjuvant chemotherapy in control study group in unresectable ca gall bladder
Intervention2: Neoadjuvant Chemoradiotherapy: comparing neoadjuvant chemoradiot
Sponsors
Dr RPGMC Tanda
Eligibility
Inclusion criteria
Inclusion criteria: histologically proven diagnosis of locally advanced GBC (adenocarcinoma) T3 or T4 tumours with one or more of the following criteria will be included in the trial 1. Liver invasion: more than 2cm but less than 5cm. 2. Radiological involvement of the antropyloric region of the stomach, duodenum, hepatic flexure of the colon or small intestine, but without infiltration of the mucosa on endoscopy. 3. Type I and II invasion: involvement of the bile duct (common hepatic duct or proximal one third of the common bile duct) on magnetic resonance cholangiopancreatography causing obstructive jaundice. 4. Radiological suspicion of regional lymph node involvement along the hepatic artery, hepatoduodenal ligament, retropancreatic or retroduodenal, size more than 1cm in short axis, round in shape and heterogeneous enhancement. 5. Vascular involvement: impingement/involvement (less than 180 degree angle) of one or more of the following blood vessels, common hepatic artery,right hepatic artery, main portal vein/right portal vein (stage III disease). 6. Patients who have undergone prior simple cholecystectomy, having residual disease with at least one of the above features. 7. The patients must have good general condition Eastern Co-operative Oncology Group (ECOG 0–2). 8. Normal haematological, renal and hepatic functions done no earlier than 2 weeks prior to treatment initiation.
Exclusion criteria
Exclusion criteria: 1. Resectable disease. 2. Distant metastatic disease (liver, lung, peritoneum and port site) 3. Extension into liver more than 5cms or involving major part of liver restricting full dose of radiotherapy. 4. Previous history of radiotherapy or chemotherapy. 5. Evidence of active cholangitis or unresolved obstructive jaundice 6. ECOG more than or equal to 3 7. Deranged complete haemogram, hepatic and renal functions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| to compare the resectability between the patients treated with NACT versus NACRT. Timepoint: At the end of treatment after 4 weeks. thereafter follow up at 3 months duration. | — |
Secondary
| Measure | Time frame |
|---|---|
| radiological response, R0 surgical resection rate, OS, PFS, acute and late toxicities, postoperative complications and quality of life (QOL) between two study arms. Timepoint: during treatment, weekly assessment, end of treatment ,post surgery and after 2 months | — |
Countries
India
Contacts
Public ContactPoorva Vias
DR Rajendra Prasad Medical College, Tanda, Kangra , Himachal Pradesh University
Outcome results
None listed