it is a phase III trial where advanced pancreatic adenocarcinoma patients will be randomised in 2 arms . 1 arm includes losartan given with folfirinox chemotherapy regime and the other arm includes fofirinox chemotherapy only .
- Conditions
- Health Condition 1: K868- Other specified diseases of pancreas
- Registration Number
- CTRI/2021/05/033482
- Lead Sponsor
- Tata Memorial Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria :
1. Histologically confirmed adenocarcinoma of the pancreas or ampulla, either by FNAC or biopsy of primary site or metastatic site, with the following specifications
a. For pancreatic adenocarcinoma - either locally advanced pancreatic cancer (unresectable) or metastatic pancreatic cancer, as per NCCN criteria, 2019
b. For ampullary adenocarcinoma - metastatic adenocarcinoma alone
2. Age 18 to 75 years.
3. ECOG performance status 0 - 1
4. Patient who can give informed consent for the study.
5. Patient does not have any contraindications to receive chemotherapy, or Losartan
6.Adequate hematological, hepatic and renal function parameters·
7. Systolic Blood pressure > 100mm Hg ( 2 separate readings)
8. Normal cardiac ejection fraction and cardiac function, as assessed by echocardiography
9. 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.
10. No major surgery within last 4 weeks
11. written patient consent form
Exclusion criteria
1. Borderline resectable pancreatic cancer, resectable pancreatic cancers, or resectable ampullary cancers
2.Known hypersensitivity or contraindications against drugs used in the FOLFIRINOX regimen or Losartan
3.Clinically significant active coronary heart disease, cardiomyopathy or congestive heart failure, NYHA II-IV,
4.Clinically significant valvular defect
5.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
6.Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
7.Other severe internal disease or acute infection
8.Baseline neuropathy > NCI Grade II
9.Chronic inflammatory bowel disease
10.Unhealed surgical wounds
11. Severe hemorrhage
12.Recent hemoptysis
13.History of GI perforation
14.Uncontrolled hypertension
15. Severe/arterial thromboembolism
16.Bilateral renal Artery stenosis
17.On-treatment participation in another clinical study in the period 30 days prior to inclusion and during the study
18.Subject pregnant or breastfeeding, or planning to become pregnant within 6 months after the end of treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate whether the addition of a drug commonly used in control of blood pressure (Losartan) will improve survival when combined with standard chemotherapy in advanced pancreatic and periampullary cancersTimepoint: 84 months
- Secondary Outcome Measures
Name Time Method 1. To check overall survival without recurrence of disease <br/ ><br> 2. To check Response rates towards different regimens <br/ ><br> 3.Side effects that will occur <br/ ><br> 4.Quality of life analysis <br/ ><br>Timepoint: 84 months