Intensity Modulated Radiation Therapy - Gyne Cancer (GY03.2)

Phase 1

Completed

• Conditions: Cervix Neoplasms; Uterine Neoplasms; Vaginal Neoplasms
• Interventions: Procedure: Intensity Modulated Radiation Therapy Boost

• Registration Number: NCT00188578
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Standard treatment for gynecological cancer is radiation therapy in two phases; whole pelvic radiation and then an internal radiation boost, also called a brachytherapy boost, to treat any remaining tumour.

The purpose of this study is to test an alternative radiation boost treatment called conformal intensity modulated radiation therapy or IMRT. Currently, we do not have complete information on the overall effectiveness of IMRT compared to brachytherapy or conformal radiotherapy. We know that IMRT allows the radiation beams to be more accurately focused on the tumor, thereby sparing more normal tissue from radiation damage and lowering risks of side effects. We are investigating the extent to which IMRT can be used to protect normal tissues in patients with cervix, uterine or vaginal cancer from the radiation beams and how much the side effects of radiation are reduced.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

Inclusion Criteria

• Biopsy-proven carcinoma of the cervix, uterus or vagina; FIGO stage T1B-4A, NO/1, MO, treated with definitive radiotherapy with or without chemotherapy, or Biopsy-proven pelvic recurrence of carcinoma of the uterus previously untreated or biopsy-proven vaginal carcinoma treated radically with radiotherapy but unsuitable for brachytherapy boost.
• Patients not suitable for intracavitary brachytherapy.
• ECOG performance status of 0, 1, or 2
• Age ≥ 18 years
• Ability to give informed consent.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMRT Gynecological Cancers	Intensity Modulated Radiation Therapy Boost	-

Primary Outcome Measures

Name	Time	Method
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.	5 years

Secondary Outcome Measures

Name	Time	Method
To evaluate the acute and late toxicity of IMRT boost.	5 years
To evaluate tumour response and patient survival data.	5 years

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada