Malignant Rectal NeoplasmPhase 2NCT01493206
A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
A Phase 2 study testing intraoperative radiotherapy in people with Malignant Rectal Neoplasm and Recurrent Tumor, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Rectal Neoplasm, Recurrent Tumor
- What is being tested?
- intraoperative radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteAustralia
- Study dates
- Jul 2004to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- unresectable pelvic disease
- distant metastasis
- significant co-morbidities
Trial locations and contacts
1 site in 1 country.
About this study
The hypothesis is that intraoperative radiotherapy for locally advanced or recurrent rectal cancer improve outcomes without causing significant side effects.
Read the 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
- Conditions
- Malignant Rectal Neoplasm, Recurrent Tumor
- Being tested
- intraoperative radiotherapy
- Keywords
- intraoperative radiotherapy
- Medical subject headings
- Rectal Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraoperative radiotherapyRadiation
intraoperative radiotherapy
| Study group | Role | What they receive |
|---|---|---|
| intraoperative radiotherapy | Experimental | Not described Receives: Radiation: intraoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical outcomes
locoregional control, progression-free and overall survival rates.
Measured: 3-year
Secondary outcomes (1)
toxicities
Toxicity score criteria defined by Intraoperative Radiation Therapy Working Group Criteria
Measured: 3-6 monthly up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJul 2004
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Rectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sam Ngan, Principal investigator, Peter MacCallum Cancer Centre, Australia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01493206
- Sponsor's protocol ID
- PMCC04/16
- Status last verified
- May 2025
- First submitted
- 13 Dec 2011
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Single Arm Study of Intraoperative Radiotherapy for Locally Advanced or Recurrent Rectal Cancer
- ClinicalTrials.gov ID
- NCT01493206
- Acronym / sponsor ID
- PMCC04/16
- Conditions
- Malignant Rectal Neoplasm, Recurrent Tumor
- Keywords
- intraoperative radiotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoperative radiotherapy | Experimental | Radiation: intraoperative radiotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (3 listed)
- unresectable pelvic disease
- distant metastasis
- significant co-morbidities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intraoperative radiotherapyintraoperative radiotherapy | Radiation | intraoperative radiotherapy |
Primary outcome
clinical outcomes
Time frame: 3-year
locoregional control, progression-free and overall survival rates.
1 secondary outcome
toxicities
Time frame: 3-6 monthly up to 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sam Ngan principal investigator
Peter MacCallum Cancer Centre, Australia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraoperative radiotherapy in people with Malignant Rectal Neoplasm and Recurrent Tumor, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical outcomes (time frame: 3-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.