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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT00188578

Collaborator

Princess Margaret Hospital, Canada (Other)

Enrollment

Location

Arm

132

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervix Neoplasms Uterine Neoplasms Vaginal Neoplasms	Procedure: Intensity Modulated Radiation Therapy Boost	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)

Study Start Date :

Jun 1, 2003

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: IMRT Gynecological Cancers	Procedure: Intensity Modulated Radiation Therapy Boost All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks

Arm

Intervention/Treatment

Experimental: IMRT Gynecological Cancers

Procedure: Intensity Modulated Radiation Therapy Boost

All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks

Outcome Measures

Primary Outcome Measures

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

To evaluate the acute and late toxicity of IMRT boost. [5 years]
To evaluate tumour response and patient survival data. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Princess Margaret Hospital, Canada

Investigators

Principal Investigator: Anthony Fyles, MD, Princess Margaret Hospital, Canada
Principal Investigator: Michael Milosevic, MD, University Health Network, Princess Margaret Hospital