Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Te... | NCT05607186

Studies
Outcomes of Neoadjuvant Therapy for Rectal Cancer in a Tertiary Asian Institute

NCT05607186

Sponsor

Singapore General Hospital

Status

Completed

Last Update Posted

Nov 7, 2022Actual

Enrollment

59Actual

Phase

Not provided

Conditions

Rectal Cancer
Oncology

Interventions

neoadjuvant long course chemoradiotherapy

Countries

Not provided

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

Oct 2022

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, 2011Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2019Actual

First Submitted Date

Oct 31, 2022

First Submission Date that Met QC Criteria

Oct 31, 2022

First Posted Date

Nov 7, 2022Actual

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

Oct 31, 2022

Last Update Posted Date

Nov 7, 2022Actual

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 is a retrospective cohort study that aims to evaluate the correlation of magnetic resonance tumour regression grade (mrTRG) and pathological TRG (pTRG) of locally advanced rectal cancer after neoadjuvant long course chemoradiotherapy as well as the prognostic value of mrTRG on survival.

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

59Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
neoadjuvant long course chemoradiotherapy	Radiation	neoadjuvant long course chemoradiotherapy consist of radiosensitizing 5FU or capecitabine and 50.4 Gy in 28 fractions over 5 weeks

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between mrTRG and pTRG		Between 1 Jan 2011 to 31 Dec 2016

Secondary Outcomes

Measure	Description	Time Frame
Prognostic value of mrTRG on survival outcomes of rectal cancer patients		Between 1 Jan 2011 to 31 Dec 2016

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Rectal cancer
At least 1 high risk feature on MRI
Undergo long course neoadjuvant chemoradiotherapy (LCCRT)

Exclusion Criteria:

metastatic disease
Patients who undergo short course radiotherapy
Patients without a repeat MRI after completion of LCCRT

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with locally advanced rectal cancer were recruited from the Department of Colorectal Surgery, Singapore General Hospital

Sampling Method

Non-Probability Sample

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
D012004	Rectal Neoplasms
D009369	Neoplasms

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided