Status:
UNKNOWN
Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Lead Sponsor:
Fudan University
Conditions:
Pancreatic Cancer
Liver Metastases
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03398291
Start Date
July 1 2018
End Date
June 1 2025
Last Update
October 9 2018
Active Locations (1)
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1
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Shanghai, Shanghai Municipality, China, 200032