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NCT06208436 Clinical Trial

The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer

Pancreas Cancer Clinical Trial

Official title:
The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer Stratified by Pathologic Risk Factors

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06208436
Other study ID # Adchmopan01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 7, 2023
Est. completion date February 28, 2024

Study information
Verified date January 2024
Source Tianjin Medical University Cancer Institute and Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aimed to evaluate the impact of adjuvant chemotherapy on survival in patients with Stage I pancreatic cancer stratified by pathologic risk factors.

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date February 28, 2024
Est. primary completion date February 15, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: Patients who underwent surgical resection and were pathologically diagnosed as PDAC between 2010 and 2021. - Exclusion Criteria: Patients with pN1-N2, patients with pT3-T4, patients with distant metastasis, patients who received neoadjuvant therapy, patients with R1 resection, and patients who died due to perioperative mortality within 30 days. -

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Adjuvant chemotherapy
Patients received adjuvant chemotherapy (5-FU-based or gemcitabine-based regimens) or underwent surgery alone

Locations
Country Name City State
China Jihui Tianjin Tianjin

Sponsors (1)
Lead Sponsor Collaborator
Tianjin Medical University Cancer Institute and Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence-free survival The period between surgical resection to the date of recurrence. January 2010 to February 2023
Secondary Overall survival The period between surgical resection to the date of death. January 2010 to February 2023
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