NCT00910494

Brief Summary

The investigators would like to test the safety and efficacy of intraoperative radiotherapy (IORT) in rectal cancer using the Photon Radiosurgery System (PRS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

May 28, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 1, 2009

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

6.2 years

First QC Date

May 28, 2009

Last Update Submit

April 22, 2018

Conditions

Rectal Neoplasm

Keywords

Rectal neoplasm C04.588.274.476.411.307.790Intraoperative Radiotherapy

Outcome Measures

Primary Outcomes (1)

  • surgical complication rate

    30 days post treatment

Secondary Outcomes (2)

  • survival

    5 year

  • local control

    5 year

Study Arms (2)

12 Gray IORT

EXPERIMENTAL
Radiation: Photon Radiosurgery System IORT

15 Gray IORT

EXPERIMENTAL
Radiation: Photon Radiosurgery System IORT

Interventions

Photon Radiosurgery System IORTRADIATION
12 Gray IORT

Eligibility Criteria

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

You may qualify if:

  • Operable rectal cancer

You may not qualify if:

  • Locally advanced disease requiring long course pre-operative chemoradiation, metastatic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Alastair Munro, MBChB

    University of Dundee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Registrar

Study Record Dates

First Submitted

May 28, 2009

First Posted

June 1, 2009

Study Start

January 1, 2010

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

GB(1)