Phase II study of dynamic intensity modulated radiotherapy in patients with borderline resectable pancreatic cancer

Phase 2

Recruiting

• Conditions: invasive pancreatic ductal adenocarcinoma; invasive pancreatic ductal adenocarcinoma, borderline resectable pancreatic cancer

• Registration Number: JPRN-jRCTs041220150
• Lead Sponsor: Mizuno Shugo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. age at the time of registry is 20 o r more, 79 or less
2. newly diagnosed invasive pancreatic ductal adenocarcinoma (PDAC) confirmed by imaging study and histological or cytological studies.
3. no distant metastasis
4. borderline resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multid etector CT imaging.
5. toleable curative resection
6. no previous anti-tumor treatment
7. Eastern Cooperative Oncology G roup performance status, 0, 1
8. adequate hematological, hepatic, renal, and cardiopulmonary functions
9. adequate ability of oral intake
10. written informed consent befor e enrolling the study

Exclusion Criteria

Patients who:
1) is allergic to the chemotherapeutic agents.
2) has pulmonary fibrosis or intestinal pneumonia.
3) has active infectious disease.
4) has simulatenous active cancer.
5) is plegnant or has possibility to become pregnant during the study.
6) is considered ineligible for enrolling the study by the principal investigator or sub-investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
histological response (Grade 1, 2, 3, 4) in the resected specimens according to the Japan Pancreas Society 7th classification

Secondary Outcome Measures

Name	Time	Method
radiographic response according to revised RECIST guideline, rate of adverse events, rate of curative-intent resection, rate of R0 resection, 2-year and 5-year overall survival rate after curative-intent resection, 2-year and 5-year overall survival rate after initial treatment, rate of postoperative complication, rate of recurrence after surgery, mode of recurrence, reasons why pancreatectomy was evaluated as not indicated, and details of treatment after discontinuation of protocol treatment