Simultaneous Resection Of Pancreatic Cancer And Liver Oligometastasis After Induction Chemotherapy

Study Overview

Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

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.

N/A

Pancreatic Cancer
Liver Metastases
Surgery

PROCEDURE: Synchronous resection of primary pancreatic cancer and liver oligometastasis
DRUG: Standard chemotherapy

CSPAC-1

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2018-01-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-10-07
First Submitted that Met QC Criteria 2018-01-07	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-10-09
First Posted (ACTUAL) 2018-01-12	Results First Posted N/A	Last Verified 2018-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
ACTIVE_COMPARATOR: Standard treatment Patients continue to receive standard chemotherapy.	DRUG: Standard chemotherapy Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1
EXPERIMENTAL: Surgical exploration Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.	PROCEDURE: Synchronous resection of primary pancreatic cancer and liver oligometastasis Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is rec

Participant Group/Arm

Intervention/Treatment

ACTIVE_COMPARATOR: Standard treatment

Patients continue to receive standard chemotherapy.

DRUG: Standard chemotherapy

Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1

EXPERIMENTAL: Surgical exploration

Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.

PROCEDURE: Synchronous resection of primary pancreatic cancer and liver oligometastasis

Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is rec

Primary Outcome Measures	Measure Description	Time Frame
Real overall survival	Including the time of induction chemotherapy	Up to 2 years

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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Xianjun Yu, M.D., Ph.D.

Phone Number: +86-21-64175590

Email: yuxianjun@fudanpci.org

Study Contact Backup

Name: Si Shi, M.D.

Phone Number: +86-21-64175590

Email: shisi@fudanpci.org

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Michalski CW, Erkan M, Huser N, Muller MW, Hartel M, Friess H, Kleeff J. Resection of primary pancreatic cancer and liver metastasis: a systematic review. Dig Surg. 2008;25(6):473-80. doi: 10.1159/000184739. Epub 2009 Feb 12.
Cannistra' M, Ruggiero M, Zullo A, Grande R, Nardo B. Surgical resection of synchronous and metachronous metastases from pancreatic adenocarcinoma. Two case reports in the light of recent evidences. Ann Ital Chir. 2015 Dec 29;86(ePub):S2239253X15024160.
Buc E, Orry D, Antomarchi O, Gagniere J, Da Ines D, Pezet D. Resection of pancreatic ductal adenocarcinoma with synchronous distant metastasis: is it worthwhile? World J Surg Oncol. 2014 Nov 18;12:347. doi: 10.1186/1477-7819-12-347.
Zanini N, Lombardi R, Masetti M, Giordano M, Landolfo G, Jovine E. Surgery for isolated liver metastases from pancreatic cancer. Updates Surg. 2015 Mar;67(1):19-25. doi: 10.1007/s13304-015-0283-6. Epub 2015 Feb 22.
Tachezy M, Gebauer F, Janot M, Uhl W, Zerbi A, Montorsi M, Perinel J, Adham M, Dervenis C, Agalianos C, Malleo G, Maggino L, Stein A, Izbicki JR, Bockhorn M. Synchronous resections of hepatic oligometastatic pancreatic cancer: Disputing a principle in a time of safe pancreatic operations in a retrospective multicenter analysis. Surgery. 2016 Jul;160(1):136-144. doi: 10.1016/j.surg.2016.02.019. Epub 2016 Apr 3.
Wei M, Shi S, Hua J, Xu J, Yu X; Chinese Study Group for Pancreatic Cancer (CSPAC). Simultaneous resection of the primary tumour and liver metastases after conversion chemotherapy versus standard therapy in pancreatic cancer with liver oligometastasis: protocol of a multicentre, prospective, randomised phase III control trial (CSPAC-1). BMJ Open. 2019 Dec 8;9(12):e033452. doi: 10.1136/bmjopen-2019-033452.

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