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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05514171
Other study ID # PaNLoCat_v4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2023

Study information

Verified date June 2024
Source Hospital del Mar
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Unlike other types of gastrointestinal tumors, there is controversial evidence of the efficacy of neoadjuvant therapy in patients with borderline and resectable adenocarcinoma (ADK) of the pancreas, the objective of this study is to perform a "snapshot" of the usual practice in our setting in terms of neoadjuvant therapy in ADK, both in terms of the different regimens used as well as the results in terms of morbidity, mortality and survival. Likewise, in a second phase, a prospective registry of patients included in the neoadjuvant regimen for both resectable and borderline ADK diagnosed in Catalonia will be launched, which will provide us with valuable information to try to answer open questions in the context of borderline and resectable ADK treatment.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 31, 2023
Est. primary completion date June 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - resectable or borderline pancreas ADK - with or without radiotherapy - any type of approach - any type of surgery Exclusion Criteria: - locally advanced ADK - No consent

Study Design


Intervention

Procedure:
Neoadyuvant therapy
Patients of group neoadyuvant therapy will receive any chemotherapy treatment before surgery

Locations

Country Name City State
Spain Hospital del Mar Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital del Mar

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Disease free survival Three years follow-up
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