Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
18 Years
75 Years
Female
Cervical Carcinoma Stage IB, Cervical Carcinoma Stage II
Trial Information
Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer
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.
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
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Evaluation of the sparing of organs at risk with a delineation at each session and the CTVhr volume modification
Outcome Description:
To record the irradiated volumes modifications of each OAR at each session and the CTV volume modification.
Outcome Time Frame:
At 8 weeks of external radiotherapy
Safety Issue:
Yes
Principal Investigator
Philippe Nickers, MD, PhD
Investigator Role:
Study Director
Investigator Affiliation:
Centre Oscar Lambret
Authority:
France: The Commission nationale de l’informatique et des libertés
Study ID:
BRACHY-HDR
NCT ID:
NCT01681342
Start Date:
May 2011
Completion Date:
May 2013
Related Keywords:
- Cervical Carcinoma Stage IB
- Cervical Carcinoma Stage II
- stade Ib to II cervix cancer
- ambulatory high dose rate brachytherapy
- Carcinoma
- Uterine Cervical Neoplasms
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