NCT00938106

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started May 2008

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 13, 2009

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 20, 2022

Status Verified

October 1, 2022

Enrollment Period

8.7 years

First QC Date

July 10, 2009

Last Update Submit

October 18, 2022

Conditions

Cervix Cancer

Keywords

Intra-uterine Brachytherapycervix cancerPatients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.

Outcome Measures

Primary Outcomes (1)

  • Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.

    36 months

Secondary Outcomes (1)

  • 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.

    36 months

Study Arms (1)

(MR BT) in Cervix Cancer

EXPERIMENTAL
Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy

Interventions

optimised magnetic resonance image-guided intra-uterine brachytherapyRADIATION

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.

(MR BT) in Cervix Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Michael Milosevic, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

May 1, 2008

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

October 20, 2022

Record last verified: 2022-10

Locations

CA(1)