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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00188578

Enrollment

Registered

2005-09-16

Start date

2003-06-30

Completion date

2014-06-30

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms

Brief 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.

Interventions

PROCEDUREIntensity Modulated Radiation Therapy Boost

All patients shall receive a continuous course of IMRT consisting of 25.2 Gy in 14 fractions over 3 weeks

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To evaluate the feasibility of using IMRT to boost the primary tumour in patients with gynecological cancers who are unsuitable for brachytherapy.	5 years

Secondary

Measure	Time frame
To evaluate the acute and late toxicity of IMRT boost.	5 years
To evaluate tumour response and patient survival data.	5 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026