Cervix NeoplasmsPhase 1/2NCT00188578
Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)
A Phase 1/2 study testing Intensity Modulated Radiation Therapy Boost in people with Cervix Neoplasms and Uterine Neoplasms, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
- What is being tested?
- Intensity Modulated Radiation Therapy Boost
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2003to Jun 2014
- Phase
- Phase 1/2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
- Patients not suitable for intracavitary brachytherapy.
- ECOG performance status of 0, 1, or 2
- Age ≥ 18 years
- Ability to give informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.
The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.
- Conditions
- Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
- Being tested
- Intensity Modulated Radiation Therapy Boost
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensity Modulated Radiation Therapy BoostProcedure or surgery
All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| IMRT Gynecological Cancers | Experimental | Not described Receives: Procedure: Intensity Modulated Radiation Therapy Boost |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.
Measured: 5 years
Secondary outcomes (2)
To evaluate the acute and late toxicity of IMRT boost.
Measured: 5 years
To evaluate tumour response and patient survival data.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix NeoplasmsStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- Anthony Fyles, MD, Principal investigator, Princess Margaret Hospital, CanadaMichael Milosevic, MD, Principal investigator, University Health Network, Princess Margaret Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188578
- Sponsor's protocol ID
- UHN REB 03-0298-C
- Status last verified
- Feb 2016
- First submitted
- 12 Sep 2005
- Last updated
- 9 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
- ClinicalTrials.gov ID
- NCT00188578
- Acronym / sponsor ID
- UHN REB 03-0298-C
- Conditions
- Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Jun 2003
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 16 Sep 2005 (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.
Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.
The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMRT Gynecological Cancers | Experimental | Procedure: Intensity Modulated Radiation Therapy Boost |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
- Patients not suitable for intracavitary brachytherapy.
- ECOG performance status of 0, 1, or 2
- Age ≥ 18 years
- Ability to give informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intensity Modulated Radiation Therapy BoostAll patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks | Procedure or surgery | IMRT Gynecological Cancers |
Primary outcome
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.
Time frame: 5 years
2 secondary outcomes
To evaluate the acute and late toxicity of IMRT boost.
Time frame: 5 years
To evaluate tumour response and patient survival data.
Time frame: 5 years
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 9 Feb 2016.
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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.
Anthony Fyles, MD principal investigator
Princess Margaret Hospital, Canada
Michael Milosevic, MD principal investigator
University Health Network, Princess Margaret Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Intensity Modulated Radiation Therapy Boost in people with Cervix Neoplasms and Uterine Neoplasms, run by University Health Network, Toronto 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 5 inclusion and 0 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 9 Feb 2016. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy. (time frame: 5 years). 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 9 Feb 2016.