Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

Phase 3

Recruiting

• Conditions: Pancreatic Cancer; Surgery; Liver Metastases
• Interventions: Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis; Drug: Standard chemotherapy

• Registration Number: NCT03398291
• Lead Sponsor: Fudan University

Brief Summary

This study is a multi-center phase 3 trial to evaluate a treatment strategy for selecting patients who can benefit from the synchronous resection of primary pancreatic cancer and liver oligometastasis after induction chemotherapy. Half of participants who meet the entry criterion will receive surgical intervention, while the other half will continue to receive standard chemotherapy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-01
• Study First Submitted QC: 2018-01-07
• Study First Posted: 2018-01-12
• Study Start: 2018-07-01
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-07
• Last Update Posted: 2018-10-09
• Primary Completion: 2023-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical exploration	Synchronous resection of primary pancreatic cancer and liver oligometastasis	Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.
Standard treatment	Standard chemotherapy	Patients continue to receive standard chemotherapy.

Primary Outcome Measures

Name	Time	Method
Real overall survival	Up to 2 years	Including the time of induction chemotherapy

Secondary Outcome Measures

Name	Time	Method
Overall survival	Up to 2 years	Not including the time of induction chemotherapy
Life quality score	Up to 2 years, every 2 months	Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Postoperative morbidity	Up to 90 days after operation	Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation
Postoperative mortality	Up to 90 days after operation	Patients die from any cause during 90 days after operation

Trial Locations

Locations (1)

Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 🇨🇳 Shanghai, Shanghai, China