Sparing of Organs at Risk in High Dose Rate Brachytherapy
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Purpose
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 feasability 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.
| Condition |
|---|
|
Cervical Carcinoma Stage IB Cervical Carcinoma Stage II |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer |
- 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 ] [ Designated as safety issue: Yes ]To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
- Evaluation of medical imaging with CT-Scan and RMN for cervix cancer [ Time Frame: At 8 weeks of external radiotherapy ] [ Designated as safety issue: No ]
- Interest of RMN sequences Water and T2 for the definition of volumes
- Evalution 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
| Estimated Enrollment: | 30 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Patients with indication of HDR brachytherapy in cervix carcinoma of stadge IB to II.
After realisation of external radiation therapy done (60 Gy in IMRT)
Inclusion Criteria:
- OMS < 2
- Tomography by positon emission and/or chirurgical stadging 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 rarte brachytherapy
- External radiation therapy (60 Gy with IMRT)
Exclusion Criteria:
- No external radiation therapy
- Cervix carcinoma stagde III and IV
- Surgery in the 4 weeks before before the inclusion
- Prior pelvic radiation therapy
- intestinal inflammatory desease or active pathology
- active infection or severe pathology didn't allowed the treatment
- Prior carcinoma in the last 5 years (except cutaneous carcinoma or in situ carcinoma)
- Inclusion in another clinical trial
Contacts and Locations| France | |
| Centre Oscar Lambret | Recruiting |
| Lille, France, 59020 | |
| Contact: Ingrid FUMAGALLI, Resident fumagalli.ingrid@gmail.com | |
| Principal Investigator: Philippe NICKERS, MD, PhD | |
| Study Director: | Philippe Nickers, MD, PhD | Centre Oscar Lambret |
More Information
No publications provided
| Responsible Party: | Centre Oscar Lambret |
| ClinicalTrials.gov Identifier: | NCT01681342 History of Changes |
| Other Study ID Numbers: | BRACHY-HDR |
| Study First Received: | September 5, 2012 |
| Last Updated: | February 12, 2013 |
| Health Authority: | France: The Commission nationale de l’informatique et des libertés |
Keywords provided by Centre Oscar Lambret:
|
stade Ib to II cervix cancer ambulatory high dose rate brachytherapy |
Additional relevant MeSH terms:
|
Carcinoma Uterine Cervical Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Uterine Neoplasms |
Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 13, 2013