Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

Pancreatic Cancer Clinical Trial

Official title:

Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03398291
• Other study ID #: CSPAC-1
• Status: Recruiting
• Phase: Phase 3
• Start date: July 1, 2018
• Est. completion date: June 1, 2025

Study information

• Verified date: October 2018
• Source: Fudan University
• Contact: Xianjun Yu, M.D., Ph.D.
• Phone: +86-21-64175590
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Liver Metastases
• Pancreatic Cancer
• Pancreatic Neoplasms
• Surgery

Intervention

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.

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

Locations

Country	Name	City	State
China	Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

References & Publications (5)

Buc E, Orry D, Antomarchi O, Gagnière 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. — View 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. — View Citation

Michalski CW, Erkan M, Hüser N, Müller 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. Review. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Real overall survival	Including the time of induction chemotherapy	Up to 2 years
Secondary	Overall survival	Not including the time of induction chemotherapy	Up to 2 years
Secondary	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
Secondary	Postoperative morbidity	Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation	Up to 90 days after operation
Secondary	Postoperative mortality	Patients die from any cause during 90 days after operation	Up to 90 days after operation