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

NCT00188578CompletedPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University Health Network, Toronto

Enrollment

12

Start Date

2003-06-01

Completion Date

2014-06-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Intensity Modulated Radiation Therapy Boost

Conditions

Cervix NeoplasmsUterine NeoplasmsVaginal Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

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

Secondary Outcomes

To evaluate the acute and late toxicity of IMRT boost.

Time frame: 5 years

To evaluate tumour response and patient survival data.

Time frame: 5 years

Locations

Princess Margaret Hospital, Toronto, Canada

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