A Prospective Single Arm Study of Intraoperative Radiothe... | NCT01493206

Studies
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer

NCT01493206

Sponsor

Peter MacCallum Cancer Centre, Australia

Status

Completed

Last Update Posted

May 31, 2025Actual

Enrollment

32Actual

Phase

Phase 2

Conditions

Malignant Rectal Neoplasm
Recurrent Tumor

Interventions

intraoperative radiotherapy

Countries

Australia

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

May 2025

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

Jul 2004

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Dec 13, 2011

First Submission Date that Met QC Criteria

Dec 13, 2011

First Posted Date

Dec 15, 2011Estimated

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

May 27, 2025

Last Update Posted Date

May 31, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.

Detailed Description

Primary Outcome measures are 3-year locoregional control, progression-free and overall survival rates.

Secondary outcome measures are toxicities scores up to 3 months after surgery (acute) and greater than 3 months after surgery (late). Data collected at 3-6 month intervals for 30 months

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intraoperative radiotherapy	Experimental		Radiation: intraoperative radiotherapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
intraoperative radiotherapy	Radiation	intraoperative radiotherapy	intraoperative radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinical outcomes	locoregional control, progression-free and overall survival rates.	3-year

Secondary Outcomes

Measure	Description	Time Frame
toxicities	Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria	3-6 monthly up to 30 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

locally advanced or recurrent rectal cancer
suitable for radical surgery but at high risk of positive resection margins,
no evidence of metastasis,
age greater than 18 years,
histologically confirmed adenocarcinoma,
ECOG performance status <2.
Informed consent

Exclusion Criteria:

unresectable pelvic disease
distant metastasis
significant co-morbidities

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sam Ngan	Peter MacCallum Cancer Centre, Australia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peter MacCallum Cancer Centre		Melbourne	Victoria	8006	Australia

Condition Browse Module

MeSH Terms

ID	Term
D012004	Rectal Neoplasms
D012008	Recurrence

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