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Failure to Adjuvant Therapy After Pancreatic Resection for Malignant Tumors

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ClinicalTrials.gov Identifier: NCT03788382
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Salvatore Paiella, MD, Universita di Verona

Brief Summary:
This study aims to evaluate the rate of patients submitted to pancreatic resection for any malignancy, who fail to access to adjuvant therapy or do not have complete adjuvant therapy. The pourpose is to give an overview concerning the most frequent conditions and or reasons associated with failure or omission of adjuvant therapy.

Condition or disease
Pancreatic Malignant Neoplasm Primary Periampullary Cancer

Detailed Description:

This prospective observational study will evaluate all patients submitted to pancreatic resection for malignancies and with indication to adjuvant therapy.

The rate of omission to adjuvant therapy and rate of failure of completion of adjuvant therapy will be evaluated as primary outcomes. As secondary outcomes, survival analyses will be performed to investigate whether this factors influence prognosis, that will be evaluated through disease free survival at 18-months. Epidemiological, intraoperative and postoperative data will be analyzed to identify conditions associated with the primary outcomes.


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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Failure to Adjuvant Therapy After Pancreatic Resection of Malignant Tumors: a Real Life Scenario
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : September 1, 2020



Primary Outcome Measures :
  1. Rate of patients who fail to receive adjuvant therapy and reasons for that [ Time Frame: 6 months ]
    The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded

  2. Rate of patients who fail to complete adjuvant therapy and reasons for that [ Time Frame: 9 months ]
    The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded


Secondary Outcome Measures :
  1. Disease free survival of patients enrolled [ Time Frame: 18 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients underwent Pancreatic Resection for Malignancies with indication for Adjuvant Therapy
Criteria

Inclusion Criteria:

  • Histologic diagnosis of pancreatic malignant tumors
  • Histologic diagnosis of biliary malignant tumors
  • Histologic diagnosis of duodenum malignant tumors
  • Histologic diagnosis of papillary malignant tumors

Exclusion Criteria:

  • Histologic diagnosis of neuroendocrine tumor (NET)
  • Histologic diagnosis of benign disease
  • Patients underwent neoadjuvant chemotherapy

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): NCT03788382


Locations
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Italy
University of Verona Hospital Recruiting
Verona, Italy, 37134
Contact: Salvatore Paiella, MD    00393283342248    salvatore.paiella@hotmail.it   
Principal Investigator: Salvatore Paiella, MD         
Sub-Investigator: Nicola Quintarelli, Med Stud         
Principal Investigator: Claudio Bassi, MD         
Principal Investigator: Roberto Salvia, MD, PhD         
Sponsors and Collaborators
Universita di Verona

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Responsible Party: Salvatore Paiella, MD, Salvatore Paiella, MD, Università di Verona, Universita di Verona
ClinicalTrials.gov Identifier: NCT03788382     History of Changes
Other Study ID Numbers: FAPR-2018
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Salvatore Paiella, MD, Universita di Verona:
Failure Adjuvant Therapy

Additional relevant MeSH terms:
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Neoplasms