Randomized Trial of Tomotherapy in Breast Cancer - Full Text View

Sponsored by:	Vrije Universiteit Brussel
Information provided by:	Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:	NCT00459628

Purpose

Tomotherapy is a new radiation therapy system that uses an integrated CT scanner during delivery of radiation treatment to improve the accuracy of the treatment. Furthermore the irradiation is delivered helicoidally allowing highly conformal shaping of dose distribution. However the magnitude of the clinical advantage of using the system in breast cancer is unknown. The purpose of the present study is to investigate whether or not the Tomotherapy can substantially reduce pulmonary and cardiac toxicities, as compared with conventional radiotherapy.

Condition	Intervention	Phase
Breast Neoplasms Mastectomy Mastectomy, Segmental	Radiation: Conventional radiotherapy Radiation: Tomotherapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mastectomy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Randomized Trial Comparing Conventional vs Short-Course Reduced Volume Conformal Post-Surgery Radiation Treatment in Women With Stage I or II Breast Cancer

Further study details as provided by Vrije Universiteit Brussel:

Primary Outcome Measures:

Pulmonary and cardiac toxicities determined by medical imaging and functional tests. [ Time Frame: Prior to treatment, 2 months after treatment, yearly for 3 years thereafter. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Local-regional recurrences. [ Time Frame: Evaluation every 3 months for 3 years, then every 4-12 months thereafter. ] [ Designated as safety issue: No ]

Estimated Enrollment:	118
Study Start Date:	May 2007
Estimated Study Completion Date:	April 2010
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
I: Active Comparator Conventional Radiotherapy Arm	Radiation: Conventional radiotherapy Radiation treatment delivered by conventional linear accelerator using matching fields
II: Experimental Tomotherapy Arm	Radiation: Tomotherapy CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system

Detailed Description:

Prior to surgery: histological confirmation; medical imaging.

Localizing markers are placed in case of breast conserving surgery.

After surgery, patients are randomized to one of two treatment arms:

Arm I: radiotherapy using tangential chest fields, and supraclavicular field in case of nodal involvement, according to our hospital's standard procedure (Voordeckers M et al, Radiother Oncol 2003;68:227 and 2004;70:225). Dose-fractionation: 50 Gy in 25 fractions over 5 weeks, 2 Gy/fraction. Additional boost 16 Gy in 8 fractions over 2 weeks if breast conserving surgery (verify marker/clip localization) and age <= 70 years.
Arm II: radiotherapy using the Tomotherapy system. Target area (breast, thorax wall, nodal areas) delimited according to pre-operative imaging and pathological description. Dose-fractionation (adapted from Whelan T et al, JNCI 2002;94:1143): 42 Gy in 15 fractions over 3 weeks, 2.8 Gy/fraction. Simultaneous boost 0.6 Gy/fraction if breast conserving surgery.

Physics quality control is integrated during treatment in both arms.

Radiotherapy begins within 6 weeks after the last breast surgery. Concurrent or sequential adjuvant systemic treatments are allowed. In case of sequential adjuvant treatment with chemotherapy first, radiotherapy begins within 6 weeks after completion of the adjuvant chemotherapy.

Quality of life, arm mobility and edema, pulmonary and heart function are assessed prior to radiotherapy, at 1-3 months after completion of radiotherapy, then yearly.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Informed consent
Histologically proven breast carcinoma
Stage I or II (T1-3N0 or T1-2N1 M0, AJCC/TNM 6th edition)
Surgery with clear margins
Pre-operative medical imaging (at least CT, MRI, and/or PET-scan)

Exclusion Criteria:

Prior breast or thoracic radiotherapy
Pregnancy or lactation
Fertile patients without effective contraception
Psychiatric or addictive disorders

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00459628

Contacts

Contact: Vincent Vinh-Hung, MD, PhD	+32 2 477 6041	conrvhgv@uzbrussel.be
Contact: Mia Voordeckers, MD	+32 2 477 6041	Mia.Voordeckers@uzbrussel.be

Locations

Belgium, Brussels
Oncologisch Centrum, UZ Brussel	Recruiting
Jette, Brussels, Belgium, 1090
Contact: Myriam Spinnoy, RN +32 2 477 6041 Myriam.Spinnoy@uzbrussel.be
Sub-Investigator: Guy Van Camp, MD, PHD
Sub-Investigator: Shane Hanon, MD
Sub-Investigator: Daniel Schuermans, RN
Sub-Investigator: Paul Bijdekerke, RN
Sub-Investigator: Mark De Ridder, MD, PhD
Sub-Investigator: Sylvia Verbanck, PhD
Sub-Investigator: Samuel Bral, MD
Sub-Investigator: Caroline Weytjens, MD
Sub-Investigator: Mia Voordeckers, MD
Sub-Investigator: Eva Swinnen
Sub-Investigator: Pierre Lievens, PhD

Sponsors and Collaborators

Vrije Universiteit Brussel

Investigators

Study Director:	Guy Storme, MD, PhD	Oncologisch Centrum, Universitair Ziekenhuis Brussel
Principal Investigator:	Vincent Vinh-Hung, MD, PhD	Radiotherapy-Oncology, Universitair Ziekenhuis Brussel

More Information

Publications:

Voordeckers M, Van de Steene J, Vinh-Hung V, Storme G. Adjuvant radiotherapy after mastectomy for pT1-pT2 node negative (pN0) breast cancer: is it worth the effort? Radiother Oncol. 2003 Sep;68(3):227-31.

Voordeckers M, Vinh-Hung V, Van de Steene J, Lamote J, Storme G. The lymph node ratio as prognostic factor in node-positive breast cancer. Radiother Oncol. 2004 Mar;70(3):225-30.

Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50.

Responsible Party:	Universitair Ziekenhuis Brussel ( Vincent Vinh-Hung )
Study ID Numbers:	2007/009, EudraCT 2007-002025-69, StK SCIE2006-30, VUB ANI47
Study First Received:	April 11, 2007
Last Updated:	June 6, 2008
ClinicalTrials.gov Identifier:	NCT00459628
Health Authority:	Belgium: Institutional Review Board

Keywords provided by Vrije Universiteit Brussel:

early breast cancer
post-operative radiation treatment

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009