Trial Information
A Pilot Study of Conformal Intensity Modulated Radiation Therapy (IMRT) for Gynaecological Cancer Patients Not Suitable for Intracavitary Brachytherapy Boost (GY03.2)
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.
Outcome Time Frame:
5 years
Safety Issue:
Yes
Principal Investigator
Anthony Fyles, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
Canada: Ethics Review Committee
Study ID:
UHN REB 03-0298-C
NCT ID:
NCT00188578
Start Date:
June 2003
Completion Date:
June 2015
Related Keywords:
- Cervix Neoplasms
- Uterine Neoplasms
- Vaginal Neoplasms
- Neoplasms
- Uterine Cervical Neoplasms
- Uterine Neoplasms
- Vaginal Neoplasms