Neo-Adjuvant therapy or surgery in carcinoma pancreas

A PROSPECTIVE RANDOMIZED CONTROL STUDY OF NEOADJUVANT CHEMO RADIOTHERAPY FOLLOWED BY SURGERY VS UPFRONT SURGERY IN RESECTABLE AND BORDERLINE RESECTABLE PANCREATIC DUCTAL ADENO CARCINOMA AND TO EVALUATE THE EFFECTS OF NEOADJUVANT THERAPY ON BODY COMPOSITION

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/05/019235

Enrollment

Registered

2019-05-20

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C250- Malignant neoplasm of head of pancreas

Interventions

Intervention1: Group â?? A: NACRT: Group-A: NACRT FOLLOWED BY SURGERY: Patients will be treated by NACRT followed by surgery. Within two weeks of randomisation, eligible patients will commence neoadju

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age more than or equal to 18 2. ECOG PS 3. Able to comply with protocol requirements and deemed fit for surgical resection, chemotherapy and radiotherapy. 4. Patients diagnosed with early or borderline resectable PDAC as per NCCN guidelines Version 1.2019 5. Histologically or cytologically proven pancreatic ductal adenocarcinoma. 6. Able to undergo biliary drainage, ERCP and stenting / PTBD

Exclusion criteria

Exclusion criteria: 1. Patients of age less than 18 years. 2. Serious medical or psychological condition precluding neoadjuvant treatment and surgical resection. 3. . Previous chemotherapy or chemoradiotherapy. 4. New York Heart Association Classification Grade III or IV 5. Patients with un-resectable disease as per NCCN Guidelines Version 1.2019 or metastatic disease at time of diagnosis. 6. Patients with histology other than adenocarcinoma will be excluded. 7. Patients with contraindications for intravenous iodinated contrast like acute or chronic renal failure. 8. Contraindication for ionizing radiation such as pregnancy.

Design outcomes

Primary

Measure	Time frame
1.To assess the response of NACRT in PDAC as per RECIST criteria version 1.1. 2.To compare resectability rate and R0 resection rate in two arms. 3. Rates of completion of intended multimodality therapy in both arms. 5.To compare operative and postoperative complications in patients receiving NACRT followed by surgery with upfront surgery group. 6.To evaluate the association between NACRT and changes in body composition and its implication on outcome and post operative outcome.Timepoint: 03 months	—

Measure

Time frame

1.To assess the response of NACRT in PDAC as per RECIST criteria version 1.1. 2.To compare resectability rate and R0 resection rate in two arms. 3. Rates of completion of intended multimodality therapy in both arms. 5.To compare operative and postoperative complications in patients receiving NACRT followed by surgery with upfront surgery group. 6.To evaluate the association between NACRT and changes in body composition and its implication on outcome and post operative outcome.Timepoint: 03 months

—

Secondary

Measure	Time frame
To compare operative and postoperative complications in patients receiving NACRT followed by surgery with upfront surgery group. To evaluate the association between NACRT and changes in body composition and its implication on outcome and post operative outcome.Timepoint: 03 months	—

Countries

India

Contacts

Public ContactProf Rajesh Gupta

PGIMER Chandigarh

rajsarakshi@gmail.com7087009639

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026