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Trial record 31 of 2945 for:    tumor | Neuroendocrine Tumors

Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment (RMPanNET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04066322
Recruitment Status : Recruiting
First Posted : August 26, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Xian-Jun Yu, Fudan University

Brief Summary:
This study is to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment. The willing of participants decide who receive surgery and who will continue to receive standard systemic treatment.

Condition or disease Intervention/treatment
Neuroendocrine Tumors Metastases Surgery Procedure: system treatment and surgery Other: system treatment

Detailed Description:
system treatments of metastatic PanNET include SSA, sunitinib, mTOR inhibitor and chemotherapy. For patients achieved PR/SD after system treatment, resection of primary tumor and metastasis maybe a better way to decline tumor burden and get longer survival. this real world study is focused on this group of patients with metastatic PanNET, and to evaluate the efficacy and tolerability of surgery in selecting patients who can benefit from the synchronous resection of primary pancreatic neuroendocrine tumor and liver metastasis after induction systemic treatment.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 180 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 4 Years
Official Title: Resection of Metastatic Pancreatic Neuroendocrine Tumors After Induction System Treatment: Real World Study
Actual Study Start Date : August 25, 2019
Estimated Primary Completion Date : July 25, 2024
Estimated Study Completion Date : July 25, 2025


Group/Cohort Intervention/treatment
system treatment
Patients continue to receive standard system treatment, including SSA, targeted therapy and chemotherapy.
Other: system treatment
to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment.

system treatment and Surgery
Patients receive synchronous resection of primary tumor and metastasis after system treatment. and treatment after surgery is based on the clinical decision.
Procedure: system treatment and surgery
to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments.
Other Name: resection of primary and metastatic tumors




Primary Outcome Measures :
  1. progression-free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]
  2. Number of Postoperative morbidity [ Time Frame: Up to 90 days after operation ]
    Including pancreatic fistula, biliary fistula, hemorrhage, wound infection, delayed gastric emptying, reoperation

  3. number of Postoperative mortality [ Time Frame: Up to 90 days after operation ]

Other Outcome Measures:
  1. number of Patients die from any cause during 90 days after operation [ Time Frame: 5 years ]
  2. progression-free survival in subgroup analysis [ Time Frame: 5 years ]
    liver metastasis type, grade, extrahepatic metastasis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with metastatic pancreatic neuroendocrine tumors in a tertiary referal center
Criteria

Inclusion Criteria:

  1. Biopsy-proven neuroendocrine tumor
  2. primary site in pancreas
  3. Advanced disease with lymph node or distant metastases (N1, M1) cannot undergoing cytoreduction by surgery/local ablative therapy at the diagnosis
  4. curative intent of all therapies possible
  5. ECOG 0-2

Exclusion Criteria:

  1. Undifferentiated neuroendocrine carcinoma or mixed neuroendocrine carcinoma secondary tumor
  2. functioning NET or advanced carcinoid heart disease
  3. part of hereditary syndrome, such as MEN1, VHL
  4. do not willing to receive systemic treatment
  5. diagnosed with other cancer within 5 years

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): NCT04066322


Contacts
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Contact: xianjun yu, MD +86 21 64175590 yuxianjun@fudanpci.org
Contact: Heli Gao +86 21 64175590 gaoheli@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   
Principal Investigator: Xianjun Yu, M.D., Ph.D.         
Sponsors and Collaborators
Fudan University
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Responsible Party: Xian-Jun Yu, Principal Investigator, Fudan University
ClinicalTrials.gov Identifier: NCT04066322    
Other Study ID Numbers: CSPAC-26
First Posted: August 26, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue