Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

NCT03398291 | Unknown Phase 3

• 1 other identifier: CSPAC-1
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Cancer; Liver Metastases; Surgery

Outcome Measures

Primary Outcomes (1)

• Real overall survival

  Including the time of induction chemotherapy

  Up to 2 years

Secondary Outcomes (4)

• Overall survival

  Up to 2 years

• Life quality score

  Up to 2 years, every 2 months

• Postoperative morbidity

  Up to 90 days after operation

• Postoperative mortality

  Up to 90 days after operation

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

Patients continue to receive standard chemotherapy.

Drug: Standard chemotherapy

Surgical exploration

EXPERIMENTAL

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

Interventions

Synchronous resection of primary pancreatic cancer and liver oligometastasis PROCEDURE

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.

Surgical exploration

Standard chemotherapy DRUG

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

Standard treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Not want to receive chemotherapy or potential operation.
• Metastases at other sites except for liver
• With other malignancies
• Receive chemotherapy, radiotherapy, and interventional therapy before
• Contraindication of potential operation
• Primary tumor and liver metastatic sites are both resectable.
• No new metastatic sites were observed
• 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.
• \. Contraindication of operation

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (6)

• 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.

  PMID: 19212120 BACKGROUND

• 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.

  PMID: 26754676 BACKGROUND

• 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.

  PMID: 25407113 BACKGROUND

• 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.

  PMID: 25702263 BACKGROUND

• 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.

  PMID: 27048934 BACKGROUND

• 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.

  PMID: 31818843 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Xianjun Yu, M.D., Ph.D.

CONTACT

+86-21-64175590; yuxianjun@fudanpci.org

Si Shi, M.D.

CONTACT

+86-21-64175590; shisi@fudanpci.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center

Study Record Dates

• First Submitted: January 1, 2018
• First Posted: January 12, 2018
• Study Start: July 1, 2018
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: October 9, 2018

Record last verified: 2018-10

Locations

CN (1)