Treatment and Outcomes of Stage III Colon Cancer in Patie... | NCT04526314

Studies
Treatment and Outcomes of Stage III Colon Cancer in Patients 80 Years of Age and Older

NCT04526314

Sponsor

Registre des Tumeurs Digestives du Finistère

Status

Completed

Last Update Posted

Aug 25, 2020Actual

Enrollment

308Actual

Phase

Not provided

Conditions

Colon Adenocarcinoma

Interventions

observational

Countries

France

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

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2018Actual

Primary Completion Date

Jan 1, 2020Actual

Completion Date

Jul 1, 2020Actual

First Submitted Date

Aug 15, 2020

First Submission Date that Met QC Criteria

Aug 24, 2020

First Posted Date

Aug 25, 2020Actual

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

Aug 24, 2020

Last Update Posted Date

Aug 25, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The objective of this study was to assess survival trends in elderly patients with stage III colon cancer

Detailed Description

This retrospective population-based study included patients aged 80 years and older with stage III colon adenocarcinoma who underwent surgery between 2007 and 2014.

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

308Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Stage 3 with adjuvant chemotherapy			Other: observational
Stage 3 without adjuvant chemotherapy			Other: observational

Interventions

Name	Type	Description	Arm Group Labels	Other Names
observational	Other	observational	Stage 3 with adjuvant chemotherapy Stage 3 without adjuvant chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Overall survival	months	2007-2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Stage 3 colon adenocarcinoma

Exclusion Criteria:

Rectal tumors
Patients receiving neo-adjuvant chemotherapy or radiotherapy
Tumours of the appendix
Tumours with histology other than adenocarcinoma

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

80 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

clinical data

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michel Robaskiewicz, MD PhD	REGISTRE DES TUMEURS DIGESTIVES DU FINISTERE	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Registre de tumeurs digestives du Finistère		Brest		29200	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33528749	Derived	Badic B, Oguer M, Cariou M, Kermarrec T, Bouzeloc S, Nousbaum JB, Robaszkiewicz M, Queneherve L. Prognostic factors for stage III colon cancer in patients 80 years of age and older. Int J Colorectal Dis. 2021 Apr;36(4):811-819. doi: 10.1007/s00384-021-03861-6. Epub 2021 Feb 2.

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration