NCT00981552

Brief Summary

A theoretical planning study to compare the normal tissue irradiation when using intensity modulated radiotherapy (IMRT) as opposed to standard radiotherapy for the definitive treatment of cervical cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Dec 2008

Shorter than P25 for early_phase_1

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

December 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

7 months

First QC Date

September 21, 2009

Last Update Submit

September 21, 2009

Conditions

Cervix Cancer

Keywords

Cervix CancerIMRTOrgan MotionTarget Definition

Outcome Measures

Primary Outcomes (1)

  • Reduction in dose to organs at risk

    6 months

Secondary Outcomes (1)

  • Target Coverage

    6 months

Study Arms (1)

Cervix Cancer

OTHER

Patients treated with cervical cancer in 2008 at Sunnybrook Odette Cancer Centre

Radiation: IMRT planningRadiation: 4-Field Radiation Planning

Interventions

IMRT planningRADIATION
Cervix Cancer
4-Field Radiation PlanningRADIATION
Cervix Cancer

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • last 60 patients treated definitively for cervical cancer at Sunnybrook Odette Cancer Centre

You may not qualify if:

  • no imaging and no anatomical description of disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Ontario, 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

  • Gillian Thomas, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2009

First Posted

September 22, 2009

Study Start

December 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

CA(1)