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

Sponsor:	University Health Network, Toronto
Collaborator:	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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Cervical Cancer Uterine Cancer Vaginal Cancer

U.S. FDA Resources

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. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To evaluate the acute and late toxicity of IMRT boost. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
To evaluate tumour response and patient survival data. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	15
Study Start Date:	June 2003
Estimated Study Completion Date:	June 2015
Estimated Primary Completion Date:	June 2015 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility

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

Criteria

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

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

Locations

Canada, Ontario
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

More Information

No publications provided

Responsible Party:	Dr Anthony Fyles, Staff Radiation Oncologist, University Health Network, Princess Margaret Hospital
ClinicalTrials.gov Identifier:	NCT00188578 History of Changes
Other Study ID Numbers:	UHN REB 03-0298-C
Study First Received:	September 12, 2005
Last Updated:	February 11, 2011
Health Authority:	Canada: Ethics Review Committee

Additional relevant MeSH terms:

Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms

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

ClinicalTrials.gov processed this record on February 08, 2012