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

University Health Network, Toronto logo

University Health Network, Toronto

Status and phase

Completed
Phase 2
Phase 1

Conditions

Cervix Neoplasms
Uterine Neoplasms
Vaginal Neoplasms

Treatments

Procedure: Intensity Modulated Radiation Therapy Boost

Study type

Interventional

Funder types

Other

Identifiers

NCT00188578
UHN REB 03-0298-C

Details and patient eligibility

About

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.

Enrollment

12 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

IMRT Gynecological Cancers
Experimental group
Treatment:
Procedure: Intensity Modulated Radiation Therapy Boost

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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