Cervix CancerEarly Phase 1NCT00981552
Dosimetric Planning Study Comparing Intensity Modulated Radiotherapy (IMRT) and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
A Early Phase 1 study testing IMRT planning and 4-Field Radiation Planning in people with Cervix Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- IMRT planning and 4-Field Radiation Planning
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2008to Sep 2009
- Phase
- Early Phase 1
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre
Who cannot join
- no imaging and no anatomical description of disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.
Read the detailed description
Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.
- Conditions
- Cervix Cancer
- Being tested
- IMRT planning, 4-Field Radiation Planning
- Keywords
- Cervix Cancer, IMRT, Organ Motion, Target Definition
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMRT planningRadiation
4-Field Radiation PlanningRadiation
| Study group | Role | What they receive |
|---|---|---|
| Cervix Cancer | Other | Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre Receives: Radiation: IMRT planning; Radiation: 4-Field Radiation Planning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in dose to organs at risk
Measured: 6 months
Secondary outcomes (1)
Target Coverage
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix CancerStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Gillian Thomas, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00981552
- Sponsor's protocol ID
- IMRTCC
- Status last verified
- Sep 2009
- First submitted
- 21 Sep 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosimetric Planning Study Comparing IMRT and 4-field Radiotherapy for Definitive Treatment of Cancer of the Cervix
- ClinicalTrials.gov ID
- NCT00981552
- Acronym / sponsor ID
- IMRTCC
- Conditions
- Cervix Cancer
- Keywords
- Cervix Cancer, IMRT, Organ Motion, Target Definition
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 22 Sep 2009 (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.
A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.
Detailed description
Radiotherapy in combination with chemotherapy is the standard treatment of locally advanced cervix cancer, however with traditional techniques large volumes of bowel and bladder are irradiated causing short-term and long-term genito-urinary and gastro-intestinal side effects. IMRT has the potential to conform precisely to the target and spare normal tissues and reduce side effects. However because there are large dose gradients there is the potential to miss the target due to organ motion. Recent studies have documented organ motion and will be used to define the target. Approximately 60 planning scans, previously used to treat patients with cervix cancer, will be used to replan using an IMRT technique and differences in doses to tumour and normal tissues compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervix Cancer | Other | Radiation: IMRT planning, Radiation: 4-Field Radiation PlanningPatients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre
Key exclusion criteria (1 listed)
- no imaging and no anatomical description of disease
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 |
|---|---|---|
| IMRT planning | Radiation | Cervix Cancer |
| 4-Field Radiation Planning | Radiation | Cervix Cancer |
Primary outcome
Reduction in dose to organs at risk
Time frame: 6 months
1 secondary outcome
Target Coverage
Time frame: 6 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 22 Sep 2009.
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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.
Gillian Thomas, MD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing IMRT planning and 4-Field Radiation Planning in people with Cervix Cancer, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 1 inclusion and 1 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 22 Sep 2009. 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 Canada. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Reduction in dose to organs at risk (time frame: 6 months). 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 22 Sep 2009; AzTrials last refreshed its copy on 31 Oct 2026.