A STUDY OF CHEMOTHERAPY FOLLOWED BY RADIOTHERAPY IN BORDERLINE RESECTABLE PANCREATIC CANCER(BRPC) AND LOCALLY ADVANCED PANCREATIC CANCER (LAPC)

Phase 2

Conditions: Health Condition 1: C259- Malignant neoplasm of pancreas, unspecified

Registration Number: CTRI/2021/10/037538

Lead Sponsor: PGIMER CHANDIGARH

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 pancreas

2. Determined borderline resectable or locally advanced.

3. Induction modified FOLFIRINOX/ Gemcitabine based combination/ Gemcitabine-nab paclitaxel up to 3cycles.

4. Stable or disease regression on re staging scans.

5. Tumour diameter 7 cm

6. Satisfying the radiation normal tissue constraints as per protocol.

7. ECOG 0,1,2

8. Patients must have acceptable organ and marrow function:

9. Ability to understand and willingness to sign an informed consent.

Exclusion Criteria

1.Tumor in growth into stomach or duodenum

2.Metastatic disease

3. Patients who have had prior radiotherapy to upper abdomen/liver.

4. Patients who have received prior chemotherapy for pancreatic cancer, other than Gemcitabine/ nab paclitaxel/ FOLFIRINOX

5. Uncontrolled intercurrent illness including but not limited to ongoing iOS active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,or psychiatric illness/ social situations that would limit compliance with study requirements.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare resectability rates and resection status (R0) in borderline respectable pancreatic cancer <br/ ><br>(BRPC) between SBRT and chemo radiation. <br/ ><br>To determine local progression free survival (LPFS) in locally advanced pancreatic cancer (LAPC)Timepoint: 3months after completion of treatment

Secondary Outcome Measures

Name	Time	Method
To evaluate acute and late toxicity <br/ ><br>To evaluate quality of life of patients before and after treatment. <br/ ><br>Comparison of doses to target volume and organs at risk between plans made on breath hol CT and free breathing CT. <br/ ><br>Analysis of peripheral immune profile, neutrophil to lymphocyte ratio , platelet to lymphocyte ratio, CD4/CD8 counts.Timepoint: Before chemotherapy, before start of SBRT, 4weeks after SBRT and 3months post SBRT