Randomized phase II trial of neoadjuvant Gemcitabine/S-1 based chemoradiotherapy for potentially resectable pancreatic ductal adenocarcinoma

Phase 2

Recruiting

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

• Registration Number: JPRN-jRCTs041200079
• Lead Sponsor: Mizuno Shugo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. age at the time of registry is 20 or 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. potentially resectable PDAC according to the resectability of Japan Pancreas Society 7th classification based on contrast enhanced multidetector CT imaging.
5. toleable curative resection
6. no previous anti-tumor treatment
7. Eastern Cooperative Oncology Group performance status, 0, 1
8. adequate hematological, hepatic, renal, and cardiopulmonary functions
9. adequate ability of oral intake
10. written informed consent before 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 curative-intent resection, degree of residual tumor, 2-year and 5-year overall survival rate, rate of postiopeative complication, rate of recurrence after surgery, mode of recurrence