Intensity Modulated Radiation Therapy - Gyne Cancer - Full Text View

Sponsors and Collaborators:	University Health Network, Toronto Princess Margaret Hospital, Canada
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00188578

Purpose

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	Intervention	Phase
Cervix Neoplasms Uterine Neoplasms Vaginal Neoplasms	Procedure: Intensity Modulated Radiation Therapy Boost	Phase I Phase II

MedlinePlus related topics: Cancer Cervical Cancer Uterine Cancer Vaginal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)

Further study details as provided by University Health Network, Toronto:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	15
Study Start Date:	June 2003

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients with gynecological tumours who have received whole pelvic radiotherapy but who are not suitable for intracavitary brachytherapy
informed consent

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00188578

Contacts

Contact: Anthony Fyles, MD

416-946-6522

anthony.fyles@rmp.uhn.on.ca

Locations

Canada, Ontario
Princess Margaret Hospital	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Anthony Fyles, MD 416-946-6522 anthony.fyles@rmp.uhn.on.ca

Sponsors and Collaborators

University Health Network, Toronto

Princess Margaret Hospital, Canada

Investigators

Principal Investigator:

Anthony Fyles, MD

Princess Margaret Hospital, Canada

More Information

Study ID Numbers:	UHN REB 03-0298-C
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00188578
Health Authority:	Canada: Ethics Review Committee

Study placed in the following topic categories:

Genital Diseases, Female
Uterine Cervical Neoplasms
Vaginal Neoplasms
Uterine Cervical Diseases
Genital Neoplasms, Female

Vaginal cancer
Uterine Diseases
Uterine Neoplasms
Vaginal Diseases
Urogenital Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009