NCT01493206

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2004

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2004

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2011

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

7.1 years

First QC Date

December 13, 2011

Last Update Submit

May 27, 2025

Conditions

Malignant Rectal NeoplasmRecurrent Tumor

Keywords

intraoperative radiotherapy

Outcome Measures

Primary Outcomes (1)

  • clinical outcomes

    locoregional control, progression-free and overall survival rates.

    3-year

Secondary Outcomes (1)

  • toxicities

    3-6 monthly up to 30 months

Study Arms (1)

intraoperative radiotherapy

EXPERIMENTAL
Radiation: intraoperative radiotherapy

Interventions

intraoperative radiotherapyRADIATION

intraoperative radiotherapy

intraoperative radiotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • unresectable pelvic disease
  • distant metastasis
  • significant co-morbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 8006, Australia

Location

MeSH Terms

Conditions

Rectal NeoplasmsRecurrence

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sam Ngan

    Peter MacCallum Cancer Centre, Australia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 13, 2011

First Posted

December 15, 2011

Study Start

July 1, 2004

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

AU(1)