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OpenTrials
Completed

NCT Number: NCT03788382

Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer

This study aims to evaluate the rate of patients submitted to pancreatic resection for pancreatic cancer, who fail to access to adjuvant therapy or do not complete adjuvant therapy. The purpose is to give an overview concerning the most frequent conditions and/or reasons associated with failure or omission of adjuvant therapy.

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Key information

Conditions

Pancreatic Malignant Neoplasm Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Verona Hospital

Verona, 37134, Italy

About this study

This prospective observational study will evaluate all patients submitted to pancreatic resection for pancreatic cancer.

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 these factors influence prognosis, that will be evaluated through a disease free survival analysis at 18-months. Epidemiological and perioperative data will be analyzed to identify conditions associated with the primary outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologic diagnosis of pancreatic cancer

Exclusion criteria

  • Non exocrine pancreatic tumors
  • Periampullary malignancies

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Disease free survival of patients enrolled

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

Universita di Verona

Other

Registry information

Official study title

Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario

Acronym: FOUNTAIN

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2018
Registry last updated
May 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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