Uterine Neoplasms Clinical Trial
Official title:
A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
Verified date | February 2016 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Ethics Review Committee |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 12 |
Est. completion date | June 2014 |
Est. primary completion date | June 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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. |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Princess Margaret Hospital | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | Princess Margaret Hospital, Canada |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy. | 5 years | Yes | |
Secondary | To evaluate the acute and late toxicity of IMRT boost. | 5 years | Yes | |
Secondary | To evaluate tumour response and patient survival data. | 5 years | Yes |
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