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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01493206




Registration number
NCT01493206
Ethics application status
Date submitted
13/12/2011
Date registered
15/12/2011
Date last updated
16/12/2011

Titles & IDs
Public title
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Scientific title
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
Secondary ID [1] 0 0
PMCC04/16
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Malignant Rectal Neoplasm 0 0
Recurrent Tumor 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - intraoperative radiotherapy

Experimental: intraoperative radiotherapy -


Treatment: Other: intraoperative radiotherapy
intraoperative radiotherapy

Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
clinical outcomes - locoregional control, progression-free and overall survival rates.
Timepoint [1] 0 0
3-year
Secondary outcome [1] 0 0
toxicities - Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Timepoint [1] 0 0
3-6 monthly up to 30 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- unresectable pelvic disease

- distant metastasis

- significant co-morbidities

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
8006 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Peter MacCallum Cancer Centre, Australia
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal
cancer improve outcomes without causing significant side effects.
Trial website
https://clinicaltrials.gov/show/NCT01493206
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Sam Ngan
Address 0 0
Peter MacCallum Cancer Centre, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications