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.

Study Overview

• Status: Recruiting
• Conditions: Pancreatic Cancer; Surgery; Liver Metastases
• Intervention / Treatment: Drug: Standard chemotherapy; Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Xianjun Yu, M.D., Ph.D.; Phone Number: 1307 +86-21-64175590; Email: yuxianjun@fudanpci.org
• Study Contact Backup: Name: Si Shi, M.D.; Phone Number: 1307 +86-21-64175590; Email: shisi@fudanpci.org

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
      • Contact: Si Shi, M.D.; Phone Number: +86-21-6417-5590; Email: shisi@fudanpci.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Note: This study has two steps. In the first step, patients who meet the criteria for candidates will receive standard first-line chemotherapy for pancreatic cancer. Response Evaluation Criteria in Solid Tumors (RECIST) criteria was employed to measure tumor's response to chemotherapy every two cycles. Until some of them meet the criteria for intervention, they will be randomized and receive relevant interventions.

Inclusion Criteria for candidates:

1. Voluntary participation
2. 18-75 years old
3. Eastern Cooperative Oncology Group (ECOG) 0-1
4. Stage IV pancreatic cancer with no more than 3 liver metastases
5. Histologically confirmed diagnosis of pancreatic cancer
6. No contraindication of chemotherapy

Exclusion Criteria for candidates:

1. Not want to receive chemotherapy or potential operation.
2. Metastases at other sites except for liver
3. With other malignancies
4. Receive chemotherapy, radiotherapy, and interventional therapy before
5. Contraindication of potential operation

Inclusion Criteria for intervention:

1. Primary tumor and liver metastatic sites are both resectable.
2. No new metastatic sites were observed
3. Abnormal serum tumor maker levels decreased by more than 50% after chemotherapy. In the serum tumor makers, carbohydrate antigen 19-9 (CA19-9) was always the first choice for evaluation and it should be below 500U/L after treatment. However, when the baseline CA19-9 was within the normal range, carbohydrate antigen 125 (CA125) and carcinoembryonic antigen (CEA) were the alternative candidate indicators.

Exclusion Criteria for intervention:

1. Contraindication of operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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 recommended to be based on the preoperative chemotherapy.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Fudan University

Publications and helpful links

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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: January 1, 2018
• First Submitted That Met QC Criteria: January 7, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): October 9, 2018
• Last Update Submitted That Met QC Criteria: October 7, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: CSPAC-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No