Trial of Tomotherapy in Breast Cancer (TomoBreast)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00459628
Recruitment Status : Active, not recruiting
First Posted : April 12, 2007
Last Update Posted : May 16, 2017
Information provided by (Responsible Party):
Vincent Vinh-Hung, MD, PhD, Vrije Universiteit Brussel

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Radiation: Conventional radiotherapy Radiation: Tomotherapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2007
Actual Primary Completion Date : August 2011
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Conventional radiotherapy
Conventional Long schedule Radiotherapy Arm
Radiation: Conventional radiotherapy
Radiation treatment delivered by conventional linear accelerator using matching fields
Other Name: Arm I, Long schedule

Experimental: Tomotherapy
Short course schedule by tomotherapy
Radiation: Tomotherapy
CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
Other Name: Arm II, Short schedule, Helical Tomotherapy

Primary Outcome Measures :
  1. Change from baseline in pulmonary function and heart function tests [ Time Frame: From end of treatment up to 3 years after treatment ]
    Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment

Secondary Outcome Measures :
  1. Local-regional recurrences. [ Time Frame: From end of treatment up to 15 years after treatment ]
    Local-regional recurrences are assessed at time intervals as per the institution's standard practice for the clinical surveillance of patients.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00459628

Oncologisch Centrum, UZ Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
Vrije Universiteit Brussel
Study Director: Mark De Ridder, MD, PhD Radiotherapy Department, Universitair Ziekenhuis Brussel
Principal Investigator: Vincent Vinh-Hung, MD, PhD Radiotherapy-Oncology, Universitair Ziekenhuis Brussel

Publications of Results:

Other Publications:
Responsible Party: Vincent Vinh-Hung, MD, PhD, Clinical Professor, Vrije Universiteit Brussel Identifier: NCT00459628     History of Changes
Other Study ID Numbers: 2007/009
2007-002025-69 ( EudraCT Number )
SCIE2006-30 ( Other Grant/Funding Number: Stichting tegen Kanker )
ANI47 ( Other Identifier: VUB )
First Posted: April 12, 2007    Key Record Dates
Last Update Posted: May 16, 2017
Last Verified: May 2017

Keywords provided by Vincent Vinh-Hung, MD, PhD, Vrije Universiteit Brussel:
early breast cancer
post-operative radiation treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases