Sparing of Organs at Risk in High Dose Rate Brachytherapy

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.

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Key information

Conditions

Cervical Carcinoma Stage IB to IV Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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)

Exclusion criteria

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)
Inclusion in another clinical trial

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Evaluation of medical imaging with CT-Scan and RMN for cervix cancer

Time frame: At 8 weeks of external radiotherapy
- 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

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Registry information

Official study title

Prospective Study on the Sparing of Organs at Risk in High Dose Rate Brachytherapy for Cervix Cancer

Important dates

Study start: 2011
Primary completion: 2013
Study completion: 2013
First posted: Sep 7, 2012
Registry last updated: Jul 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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