Cervical Carcinoma Stage IB to IVNCT01681342
Sparing of Organs at Risk in High Dose Rate Brachytherapy
An observational study of Cervical Carcinoma Stage IB to IV, run by Centre Oscar Lambret at 1 site in France.
Trial summary
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Cervical Carcinoma Stage IB to IV
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2011to Feb 2013
- Phase
- Observational
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II. After realization of external radiation therapy done (60 Gy in IMRT)
Who may be able to join
- Cervix carcinoma stage Ib to IV (FIGO)
- OMS < 2
- Tomography by positron emission and/or chirurgical staging before the external radiotherapy
- RMN before the starting of treatment and at the end af external radiotherapy
- Patient information
- Validation of the indication af high dose rate brachytherapy
- External radiation therapy (60 Gy with IMRT)
Who cannot join
- No external radiation therapy
- Surgery in the 4 weeks before before the inclusion
- Prior pelvic radiation therapy
- intestinal inflammatory disease or active pathology
- active infection or severe pathology didn't allow the treatment
- Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.
In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.
Read more
The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.
This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.
Read the detailed description
After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.
A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.
During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.
- Conditions
- Cervical Carcinoma Stage IB to IV
- Keywords
- stade Ib to IV cervix cancer, ambulatory high dose rate brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
Measured: At 8 weeks of external radiotherapy
Secondary outcomes (1)
Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
- Interest of RMN sequences Water and T2 for the definition of volumes
- Evaluation of imaging registration on the planning treatment system based on the brachytherapy applicator for the precision of volumes delineation
- Evaluate the interest of TDM and RMN for volumes delineation
Measured: At 8 weeks of external radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2011
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Carcinoma Stage IB to IVStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Nickers, MD, PhD, Study director, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681342
- Sponsor's protocol ID
- BRACHY-HDR
- Status last verified
- Jul 2013
- First submitted
- 5 Sep 2012
- Last updated
- 25 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
- ClinicalTrials.gov ID
- NCT01681342
- Acronym / sponsor ID
- BRACHY-HDR
- Conditions
- Cervical Carcinoma Stage IB to IV
- Keywords
- stade Ib to IV cervix cancer, ambulatory high dose rate brachytherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 7 Sep 2012 (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.
Cervix carcinoma is a common malignancy. Radiation therapy still remains a major treatment for patients with carcinoma cervix. Conventional treatment with radiation therapy includes a combination of external beam radiation therapy and intracavitary treatment. Low dose rate intracavitary brachytherapy treatment is already well studied. But high dose rate brachytherapy is a relatively new alternative.
In brachytherapy, major developments have been made in the integration of 3D imaging and computerized 3D treatment planning. Medical imaging improvements allowed for better definition of tumoral volumes and organs at risk.
The GYN GEC-ESTRO published recommendations on the 3D imaging for better characterization of these volumes. Improvements in CT-SCan and lately in RMN had lead to a better definition of volums of interest (tumor and his extensions and organs at risk : bladder, rectum, sigmoidis, small bowels). RMN is the imaging standard in the evaluation of tumoral extension in cervix cancer. However its use is not easy in many brachytherapy departments.
This study will evaluate the feasibility and sparing of organs at risk for high dose rate brachytherapy if volume delineation is done at each of the two sessions performed with 3D RMN.
Detailed description
After 60 Gy are delivered with Intensity Modulated Radiation Therapy (IMRT), the brachytherapy in high dose rate will deliver 15 Gy to the CTVhr (high risk CTV) in two sessions.
A clinical examination and an RMN are performed at the end of the external radiation to evaluate the residual tumoral volume. Two HDR brachytherapy sessions are then performed.
During the first session, a CT-Scan and an RMN will be performed after the fletcher application. A second CT-Scan will be performed during the second treatment session to create new volumes and to improve organs at risk sparing.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with indication of HDR brachytherapy in cervix carcinoma of stage IB to II. After realization of external radiation therapy done (60 Gy in IMRT)
Key inclusion criteria (7 listed)
- Cervix carcinoma stage Ib to IV (FIGO)
- OMS < 2
- Tomography by positron emission and/or chirurgical staging before the external radiotherapy
- RMN before the starting of treatment and at the end af external radiotherapy
- Patient information
Key exclusion criteria (6 listed)
- No external radiation therapy
- Surgery in the 4 weeks before before the inclusion
- Prior pelvic radiation therapy
- intestinal inflammatory disease or active pathology
- active infection or severe pathology didn't allow the treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
Time frame: At 8 weeks of external radiotherapy
To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
1 secondary outcome
Evaluation of medical imaging with CT-Scan and RMN for cervix cancer
Time frame: At 8 weeks of external radiotherapy
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 25 Jul 2013.
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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.
Philippe Nickers, MD, PhD study director
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cervical Carcinoma Stage IB to IV, run by Centre Oscar Lambret at 1 site in France.
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 6 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 25 Jul 2013. 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 France. 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.
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?
Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification (time frame: At 8 weeks of external radiotherapy). 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 25 Jul 2013.