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

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188578
• Other study ID #: UHN REB 03-0298-C
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 12, 2005
• Last updated: February 8, 2016
• Start date: June 2003
• Est. completion date: June 2014

Study information

• 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

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Neoplasms
• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Neoplasms

Intervention

Procedure:
• Intensity Modulated Radiation Therapy Boost
All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

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