Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00938106
First received: July 10, 2009
Last updated: June 24, 2014
Last verified: June 2014
  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: 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:


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 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (MR BT) in Cervix Cancer Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy
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
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: NCT00938106

Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Michael Milosevic, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00938106     History of Changes
Other Study ID Numbers: UHN REB 08-0206-C
Study First Received: July 10, 2009
Last Updated: June 24, 2014
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 September 18, 2014