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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard treatment | Active Comparator | Patients continue to receive standard chemotherapy. |
|
| Surgical exploration | Experimental | Patients receive surgical exploration and synchronous resection of primary pancreatic cancer and liver oligometastasis will be performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Real overall survival | Including the time of induction chemotherapy | Up to 2 years |
| 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 |
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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:
Exclusion Criteria for candidates:
Inclusion Criteria for intervention:
Exclusion Criteria for intervention:
1. Contraindication of operation
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xianjun Yu, M.D., Ph.D. | Contact | +86-21-64175590 | 1307 | yuxianjun@fudanpci.org |
| Si Shi, M.D. | Contact | +86-21-64175590 | 1307 | shisi@fudanpci.org |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19212120 | Background | 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. | |
| 26754676 | 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. |
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|
| 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 |
|
| 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 |
|
| 25407113 | 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. |
| 25702263 | 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. |
| 27048934 | 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. |
| 31818843 | Derived | 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. |
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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