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

Recurrent Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01493206
• Other study ID #: PMCC04/16
• Status: Completed
• Phase: Phase 2
• First received: December 13, 2011
• Last updated: December 14, 2011
• Start date: July 2004
• Est. completion date: August 2011

Study information

• Verified date: December 2011
• Source: Peter MacCallum Cancer Centre, Australia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malignant Rectal Neoplasm
• Rectal Neoplasms
• Recurrent Tumor

Intervention

Radiation:
• intraoperative radiotherapy
intraoperative radiotherapy

Locations

Country	Name	City	State
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria

Sponsors (1)

Lead Sponsor	Collaborator
Peter MacCallum Cancer Centre, Australia

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	clinical outcomes	locoregional control, progression-free and overall survival rates.	3-year	No
Secondary	toxicities	Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria	3-6 monthly up to 30 months	Yes