NCT06208436

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 7, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

4 months

First QC Date

December 25, 2023

Last Update Submit

January 6, 2024

Conditions

Pancreas CancerChemotherapy

Outcome Measures

Primary Outcomes (1)

  • Recurrence-free survival

    The period between surgical resection to the date of recurrence.

    January 2010 to February 2023

Secondary Outcomes (1)

  • Overall survival

    January 2010 to February 2023

Study Arms (1)

TMUCIH-PDAC

Between 2010 and 2021, the data of patients who underwent surgical resection and were pathologically diagnosed as PDAC from Tianjin Medical University Cancer Institute and Hospital (TMUCIH) were collected retrospectively.

Other: Adjuvant chemotherapy

Interventions

Adjuvant chemotherapyOTHER

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

TMUCIH-PDAC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Stage I PDAC patients who underwent radical surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jihui

Tianjin, Tianjin Municipality, 300202, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 25, 2023

First Posted

January 17, 2024

Study Start

October 7, 2023

Primary Completion

February 15, 2024

Study Completion

February 28, 2024

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)