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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms

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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

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