Health Condition 1: C23- Malignant neoplasm of gallbladder Health Condition 2: O- Medical and Surgical
Conditions
Interventions
Intervention1: Surgery plus chemotherapy Gmecitabine Cisplatin and Nab paclitaxel: Neoadjuvant and Adjuvant chemotherapy Gemcitabine Cisplatin and Nab Paclitaxel. Surgery will be sandwiched between ne
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1.Histologically confirmed adenocarcinoma (FNAC or biopsy) of the gallbladder 2.No radiological or clinical evidence of metastatic disease and no evidence of metastatic disease as discovered by on-table evaluation during definitive surgery 3.Patients presenting with pT3 or/and pN + disease after simple cholecystectomies who are non-metastatic and still resectable 4.The patients who present with upfront cT3 and or cN+ disease and are non-metastatic and resectable 5.The patients who present with upfront cT2 and cN+ disease and are non-metastatic and resectable 6.Operable disease decided in MDT 7.ECOG performance status 0 - 1 8.Patient does not have any contraindications to receive chemotherapy 9.Adequate hematological, hepatic and renal function parameters - hematological- Hb greater than 80 g/L, ANC greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L. Liver functions- bilirubin lesser than or equal to 2 x upper limit normal (ULN), AST/ALT lesser than or equal to 5 x ULN, S. albumin greater than or equal to 2.8 g/L 10.Renal function- Creatinine lesser than or equal to 1.5 ULN, Creatinine clearance greater than or equal to 50 mL/min. 11.Women of childbearing age should have a negative pregnancy test at the time of randomization and should be willing to use adequate contraception during the treatment phase of the trial.
Exclusion criteria
Exclusion criteria: 1.Known hypersensitivity or contraindications against gemcitabine, cisplatin, Nab-Paclitaxel or CAPECITABINE or radiation therapy. 2.Radiological T1 patients will not be included if radiologists are sure about the cT1 at presentation 3.Clinically significant active coronary heart disease, cardiomyopathy, valvular heart disease or congestive heart failure, NYHA III-IV, 4.Past or current history of other malignancies not curatively treated and without evidence of disease for more than 5 years, except for curatively treated basal cell carcinoma of the skin and in situ carcinoma of the cervix 5.Other severe internal disease or acute infection 6.Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers.Timepoint: To evaluate difference in OS at 36 months between perioperative gemcitabine-cisplatin- nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by surgery and adjuvant gemcitabine-cisplatin) and upfront surgery and adjuvant oral CAPECITABINEand concurrent cape-RT for in operable Gall BladderCancers. Assessments will be done at baseline and after every 4 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate difference in DFS at 36 months between perioperative gemcitabine-cisplatin- nabPaclitaxel (sequence of neoadjuvant Gemcitabine-Cisplatin - nabPAclitaxel followed by surgery & adjuvant gemcitabine-cisplatin) & upfront surgery & adjuvant oral CAPECITABINE for in operable Gall BladderCancers. 1.To assess the QOL of these patients in each of these arms. 2.To evaluate differences in R0 resection rates between the two arms 3.To evaluate differences in resection rates between the two arms 4.To evaluate differences in treatment completion rates between the two arms 5.To evaluate differences in treatment related adverse event profiles between the two armsTimepoint: 36 months | — |
Countries
India
Contacts
Public ContactDr Vikas Ostwal
Tata Memorial Hospital
Outcome results
None listed