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

NCT00188578 | Completed Phase 1

• 1 other identifier: UHN REB 03-0298-C
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervix Neoplasms; Uterine Neoplasms; Vaginal Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• To evaluate the acute and late toxicity of IMRT boost.

  5 years

• To evaluate tumour response and patient survival data.

  5 years

Study Arms (1)

IMRT Gynecological Cancers

EXPERIMENTAL

Procedure: Intensity Modulated Radiation Therapy Boost

Interventions

Intensity Modulated Radiation Therapy Boost PROCEDURE

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

IMRT Gynecological Cancers

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Vaginal Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases

Study Officials

• Anthony Fyles, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

• Michael Milosevic, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: June 1, 2003
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

CA (1)