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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01493206

Enrollment

Registered

2011-12-15

Start date

2004-07-31

Completion date

2011-08-31

Last updated

2025-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Rectal Neoplasm, Recurrent Tumor

Keywords

intraoperative radiotherapy

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

Interventions

RADIATIONintraoperative radiotherapy

intraoperative radiotherapy

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026