Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer - Full Text View

Sponsor:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00938106

Purpose

Patients with cervix cancer usually require external radiation given to the whole pelvis then an internal radiation boost, also called brachytherapy, to treat any remaining tumour. Standard brachytherapy has been used successfully for many years, but does not take into account differences in the shape of the tumour or normal structures between patients. This study aims to implement individualized -optimized- brachytherapy, based on international recommendations. MR scanning with the intra-uterine applicator in place allows improved identification of residual tumour and normal structures, allowing brachytherapy to be individualized for each patient with the aim to reduce side-effects and improve outcome. Additionally, repeating MR scans during brachytherapy treatment will allow further assessment on motion of the applicator during treatment and the effect on radiation dose. Sexual health assessments aim to identify the relationship between sexual health and treatment effects.

Condition	Intervention	Phase
Cervix Cancer	Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Determine local control,overall survival,acute & late toxicity, & sexual health of patients treated with optimised intra-uterine BT. Evaluate stability of the intra-uterine applicator during BT. Evaluate dose homogeneity of BT for cervix cancer. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Intervention Details:

Brachytherapy treatment will be planned based on the MRI test and will be individualized for each study participant,based on participant's cancer and body inside.Brachytherapy will be as an inpatient over 2-3 days. All other care will follow standard procedures.

Detailed Description:

Pre-treatment: Prior to examination under anaesthesia and placement of the intra-uterine applicator, in addition to standard assessment of treatment toxicity, the patient may complete an optional Sexual Health assessment taking approximately 15 minutes. Following standard insertion of the intra-uterine applicator under general anaesthetic and planning MRI scan, there is an optional additional MRI scan taking an extra 30 minutes This extra scan will not affect the commencement of treatment planning as images from the planning scan will be transferred to the treatment planning system as soon as they are obtained. From the MRi planning scan, target and specific normal structures are contoured. An individual BT plan will be derived based on a standard plan to deliver dose within specified dose volume constraints.

During treatment: During inpatient BT optional MRI scans, each taking 15 minutes will be obtained in the period between treatment pulses once during each 24 hours of admission. The information from the additional MRI scans will not be used to alter or influence treatment.

Follow-up: Standard follow-up procedures will be followed, with the optional addition of the Sexual Health evaluation at each visit.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age over 18 years
ECOG performance status 0-2
Histological confirmed carcinoma cervix
Decision to treat with EBRT (+/- concurrent chemotherapy), and PDR BT
Ability to comply with study protocol
Patient informed consent

Exclusion Criteria:

Unable to or unwilling to give informed consent
Not suitable for intra-uterine brachytherapy
Previous treatment for pelvic malignancy
Previous pelvic radiotherapy
Serious claustrophobia
Previous history of metallic injury to the eye
Non-removable implants contraindicated for MRI
Cardiac pacemaker
Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00938106

Contacts

Contact: Michael Milosevic, MD

416 946 4501 ext 6522

michaeal.milosevic@rmp.uhn.on.ca

Locations

Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Michael Milosevic, MD 416 946 4501 ext 6522 michael.milosevic@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Michael Milosevic, MD

University Health Network, Princess Margaret Hospital

More Information

No publications provided

Responsible Party:	Dr. Michael Milosevic, Staff Radiation Oncologist, Clinician Scientist, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier:	NCT00938106 History of Changes
Other Study ID Numbers:	UHN REB 08-0206-C
Study First Received:	July 10, 2009
Last Updated:	August 10, 2010
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Intra-uterine Brachytherapy
cervix cancer
Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 23, 2012