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Trial record 36 of 2891 for:    Pancreatic Cancer AND pancreas

Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy

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ClinicalTrials.gov Identifier: NCT03398291
Recruitment Status : Recruiting
First Posted : January 12, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Liver Metastases Surgery Procedure: Synchronous resection of primary pancreatic cancer and liver oligometastasis Drug: Standard chemotherapy Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Simultaneous Resection of Pancreatic Cancer and Liver Oligometastasis After Induction Chemotherapy
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2025

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard treatment
Patients continue to receive standard 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

Experimental: Surgical exploration
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
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.




Primary Outcome Measures :
  1. Real overall survival [ Time Frame: Up to 2 years ]
    Including the time of induction chemotherapy


Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 2 years ]
    Not including the time of induction chemotherapy

  2. Life quality score [ Time Frame: Up to 2 years, every 2 months ]
    Quality of life will be measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30

  3. Postoperative morbidity [ Time Frame: Up to 90 days after operation ]
    Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation

  4. Postoperative mortality [ Time Frame: Up to 90 days after operation ]
    Patients die from any cause during 90 days after operation



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398291


Contacts
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Contact: Xianjun Yu, M.D., Ph.D. +86-21-64175590 ext 1307 yuxianjun@fudanpci.org
Contact: Si Shi, M.D. +86-21-64175590 ext 1307 shisi@fudanpci.org

Locations
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China, Shanghai
Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: XianJun Yu, M.D., Ph.D.    +86-21-6417-5590    yuxianjun@fudanpci.org   
Contact: Si Shi, M.D.    +86-21-6417-5590    shisi@fudanpci.org   
Principal Investigator: Xianjun Yu, M.D., Ph.D.         
Sponsors and Collaborators
Fudan University

Publications:
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Responsible Party: Xian-Jun Yu, Chair of Department of Pancreatic Surgery, Fudan University Shanghai Cancer Center, Fudan University
ClinicalTrials.gov Identifier: NCT03398291     History of Changes
Other Study ID Numbers: CSPAC-1
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Liver Extracts
Hematinics