Sparing of Organs at Risk in High Dose Rate Brachytherapy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Oscar Lambret
ClinicalTrials.gov Identifier:
NCT01681342
First received: September 5, 2012
Last updated: July 24, 2013
Last verified: July 2013
  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 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.


Condition
Cervical Carcinoma Stage IB to IV

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

Resource links provided by NLM:


Further study details as provided by Centre Oscar Lambret:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
    • 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


Enrollment: 24
Study Start Date: June 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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)

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01681342

Locations
France
Centre Oscar Lambret
Lille, France, 59020
Sponsors and Collaborators
Centre Oscar Lambret
Investigators
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: July 24, 2013
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Oscar Lambret:
stade Ib to IV cervix cancer
ambulatory high dose rate brachytherapy

ClinicalTrials.gov processed this record on October 19, 2014