Back to resultsSimultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Primary Purpose
Pancreatic Cancer, Liver Metastases, Surgery
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Synchronous resection of primary pancreatic cancer and liver oligometastasis
Standard chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer
Eligibility Criteria
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:
- Voluntary participation
- 18-75 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
Exclusion Criteria for candidates:
- 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
Inclusion Criteria for intervention:
- 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.
Exclusion Criteria for intervention:
1. Contraindication of operation
Sites / Locations
- Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard treatment
Surgical exploration
Arm Description
Patients continue to receive standard chemotherapy.
Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.
Outcomes
Primary Outcome Measures
Real overall survival
Including the time of induction chemotherapy
Secondary Outcome Measures
Overall survival
Not including the time of induction chemotherapy
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
Postoperative morbidity
Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation
Postoperative mortality
Patients die from any cause during 90 days after operation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03398291
Brief Title
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Official Title
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer, Liver Metastases, Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard treatment
Arm Type
Active Comparator
Arm Description
Patients continue to receive standard chemotherapy.
Arm Title
Surgical exploration
Arm Type
Experimental
Arm Description
Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed.
Intervention Type
Procedure
Intervention Name(s)
Synchronous resection of primary pancreatic cancer and liver oligometastasis
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Intervention Description
Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1
Primary Outcome Measure Information:
Title
Real overall survival
Description
Including the time of induction chemotherapy
Time Frame
Up to 2 years
Secondary Outcome Measure Information:
Title
Overall survival
Description
Not including the time of induction chemotherapy
Time Frame
Up to 2 years
Title
Life quality score
Description
Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
Time Frame
Up to 2 years, every 2 months
Title
Postoperative morbidity
Description
Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation
Time Frame
Up to 90 days after operation
Title
Postoperative mortality
Description
Patients die from any cause during 90 days after operation
Time Frame
Up to 90 days after operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Voluntary participation
18-75 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
Exclusion Criteria for candidates:
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
Inclusion Criteria for intervention:
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.
Exclusion Criteria for intervention:
1. Contraindication of operation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xianjun Yu, M.D., Ph.D.
Phone
+86-21-64175590
Ext
1307
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name or Official Title & Degree
Si Shi, M.D.
Phone
+86-21-64175590
Ext
1307
Email
shisi@fudanpci.org
Facility Information:
Facility Name
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
XianJun Yu, M.D., Ph.D.
Phone
+86-21-6417-5590
Email
yuxianjun@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Si Shi, M.D.
Phone
+86-21-6417-5590
Email
shisi@fudanpci.org
First Name & Middle Initial & Last Name & Degree
Xianjun Yu, M.D., Ph.D.
12. IPD Sharing Statement
Citations:
PubMed Identifier
19212120
Citation
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.
Results Reference
background
PubMed Identifier
26754676
Citation
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.
Results Reference
background
PubMed Identifier
25407113
Citation
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.
Results Reference
background
PubMed Identifier
25702263
Citation
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.
Results Reference
background
PubMed Identifier
27048934
Citation
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.
Results Reference
background
PubMed Identifier
31818843
Citation
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.
Results Reference
derived
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Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
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