Health Condition 1: C23- Malignant neoplasm of gallbladder
Conditions
Interventions
Intervention1: Gemcitabine and Cisplatin and nab paclitaxel: The intravenous intervention will be administer to the patients until disease progression or unacceptable severe toxicity.
Nab Paclitaxel 1
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Histologically confirmed adenocarcinoma of the gallbladder with the following specifications 1. Locally advanced unresectable or metastatic on radiology 2. Age more than 18 years 3. ECOG performance status 0-2 4. Patient who can give informed consent for the study. 5. Patient does not have any contraindications to receive chemotherapy 6. Adequate Hematological, hepatic and renal function parameters 7. ECG within acceptable limits 8. 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. Distal cholangiocarcinoma,intrahepatic or perihilar cholangiocarcinomas 2. Known hypersensitivity or contraindications against gemcitabine, cisplatin, oxaliplatin,albumin bound paclitaxel and carboplatin 3. Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure,NYHA III to IV, clinically significant valvular defect 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. Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy 6. Other severe internal disease or acute infection 7. Baseline neuropathy more than NCI Grade I 8. Chronic inflammatory bowel disease 9. On treatment participation in another clinical study in the period 30 days prior to inclusion and during the study 10. Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment. 11. Patients who have completed adjuvant Gem or Platinum based chemotherapy within 6 months. 12. Received any prior chemotherapy or radiotherapy or cancer directed therapy within the last 5 years (excepting as adjuvant therapy as indicated prior) 13. Any active ILD or history of lung illness requiring bronchodilator drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the study is to compare the overall survival (OS) of the GAP regimen to Gemcitabine platinum combination.Timepoint: The study duration is of 48 months. Total around 350 patients will be screened and 255 eligible patients shall be included in this study over 36 months period.Patients will be followed for 12 months. Response assessment scans will be performed at baseline and after every 4 cycles. QOL analysis will be conducted at the following time intervals (approximate) at Baseline At approximately 3 months and 6 months post starting therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints The secondary endpoints and objectives include 1. To compare the progression free survival (PFS) of the GAP regimen to Gemcitabine platinum combination. 2. To compare the toxicity of the GAP regimen to Gemcitabine platinum combination. 3. To compare the tolerance of the GAP regimen to Gemcitabine platinum combination. 4. To compare the quality of life of the GAP regimen to Gemcitabine platinum combination.Timepoint: The total study duration is of 48 months | — |
Countries
India
Contacts
Public ContactDr Anant Ramaswamy
Tata Memorial Hospital
Outcome results
None listed