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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00188578
Other study ID # UHN REB 03-0298-C
Secondary ID
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


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
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