Pancreatic Malignant Neoplasm PrimaryFOUNTAINNCT03788382
Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer
An observational study of Pancreatic Malignant Neoplasm Primary, run by Universita di Verona at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Malignant Neoplasm Primary
- How many people
- 317 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jan 2019to 28 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients submitted to Pancreatic Resection for Pancreatic Cancer
Who may be able to join
- Histologic diagnosis of pancreatic cancer
Who cannot join
- Non exocrine pancreatic tumors
- Periampullary malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario
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.
Read the detailed description
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.
- Conditions
- Pancreatic Malignant Neoplasm Primary
- Keywords
- Failure Adjuvant Therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients who fail to receive adjuvant therapy and reasons for that
The amount of patients who will not receive adjuvant therapy after pancreatic resection for malignancy (when do indication exists) will be recorded
Measured: 6 months
Rate of patients who fail to complete adjuvant therapy and reasons for that
The amount of patients who will not complete adjuvant therapy after pancreatic resection for malignancy will be recorded
Measured: 9 months
Secondary outcomes (1)
Disease free survival of patients enrolled
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2018
- Study start1 Jan 2019
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Malignant Neoplasm PrimaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 317 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universita di Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salvatore Paiella, MD, Universita di Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03788382
- Sponsor's protocol ID
- FOUNTAIN
- Acronym
- FOUNTAIN
- Status last verified
- May 2024
- First submitted
- 21 Dec 2018
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Paiella S, Malleo G, Lionetto G, Cattelani A, Casciani F, Secchettin E, De Pastena M, Bassi C, Salvia R. Adjuvant Therapy After Upfront Resection of Resectable Pancreatic Cancer: Patterns of Omission and Use-A Prospective Real-Life Study. Ann Surg Oncol. 2024 May;31(5):2892-2901. doi: 10.1245/s10434-024-14951-4. Epub 2024 Jan 29.
PubMed 38286884
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Failure to Adjuvant Therapy After Pancreatic Resection for Pancreatic Cancer: a Real Life Scenario
- ClinicalTrials.gov ID
- NCT03788382
- Acronym / sponsor ID
- FOUNTAIN / FOUNTAIN
- Conditions
- Pancreatic Malignant Neoplasm Primary
- Keywords
- Failure Adjuvant Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 317 participants (actual)
- Lead sponsor
- Universita di VeronaUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 27 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients submitted to Pancreatic Resection for Pancreatic Cancer
Key inclusion criteria (1 listed)
- Histologic diagnosis of pancreatic cancer
Key exclusion criteria (2 listed)
- Non exocrine pancreatic tumors
- Periampullary malignancies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
1 secondary outcome
Disease free survival of patients enrolled
Time frame: 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Derived from this study: PubMed 38286884Paiella S, Malleo G, Lionetto G, Cattelani A, Casciani F, Secchettin E, De Pastena M, Bassi C, Salvia R. Adjuvant Therapy After Upfront Resection of Resectable Pancreatic Cancer: Patterns of Omission and Use-A Prospective Real-Life Study. Ann Surg Oncol. 2024 May;31(5):2892-2901. doi: 10.1245/s10434-024-14951-4. Epub 2024 Jan 29.
Related trials for Pancreatic Malignant Neoplasm Primary
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
Advanced Cancer, Metastatic Cancer
Active, not recruitingPhase 1
Determining the Biodistribution of an Imaging Tracer (68Ga-FAPi-46) in Patients With Solid Tumors or Hematologic Cancers
Anal Carcinoma, Bladder Carcinoma
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Malignant Neoplasm Primary, run by Universita di Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of patients who fail to receive adjuvant therapy and reasons for that (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03788382, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.