The Survival Outcome of Adjuvant Chemotherapy for Stage I... | NCT06208436

Studies
The Survival Outcome of Adjuvant Chemotherapy for Stage I Pancreatic Cancer

NCT06208436

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Status

Unknown status

Last Update Posted

Jan 17, 2024Actual

Enrollment

250Estimated

Phase

Not provided

Conditions

Pancreas Cancer
Chemotherapy

Interventions

Adjuvant chemotherapy

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2023Actual

Primary Completion Date

Feb 15, 2024Estimated

Completion Date

Feb 28, 2024Estimated

First Submitted Date

Dec 25, 2023

First Submission Date that Met QC Criteria

Jan 6, 2024

First Posted Date

Jan 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 6, 2024

Last Update Posted Date

Jan 17, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jihui Hao, Professor, Tianjin Medical University Cancer Institute and HospitalPrincipal Investigator

Lead Sponsor

Tianjin Medical University Cancer Institute and HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Adjuvant chemotherapy	Other	Patients received adjuvant chemotherapy (5-FU-based or gemcitabine-based regimens) or underwent surgery alone	TMUCIH-PDAC

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Recurrence-free survival	The period between surgical resection to the date of recurrence.	January 2010 to February 2023

Secondary Outcomes

Measure	Description	Time Frame
Overall survival	The period between surgical resection to the date of death.	January 2010 to February 2023

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Stage I PDAC patients who underwent radical surgery.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Jihui	Recruiting	Tianjin	Tianjin Municipality	300202	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017024	Chemotherapy, Adjuvant

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy

Browse Leaves

Not provided

Browse Branches

Not provided