Trial of Tomotherapy in Breast Cancer (TomoBreast)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Vincent Vinh-Hung, MD, PhD, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier:
NCT00459628
First received: April 11, 2007
Last updated: September 8, 2014
Last verified: September 2014
  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
Radiation: Conventional radiotherapy
Radiation: Tomotherapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Vrije Universiteit Brussel:

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


Secondary Outcome Measures:
  • Local-regional recurrences. [ Time Frame: From end of treatment up to 15 years after treatment ] [ Designated as safety issue: No ]
    Local-regional recurrences are assessed at time intervals as per the institution's standard practice for the clinical surveillance of patients.


Estimated Enrollment: 118
Study Start Date: May 2007
Estimated Study Completion Date: December 2016
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

Publications:

Responsible Party: Vincent Vinh-Hung, MD, PhD, Clinical Professor, Vrije Universiteit Brussel
ClinicalTrials.gov Identifier: NCT00459628     History of Changes
Other Study ID Numbers: 2007/009, 2007-002025-69, SCIE2006-30, ANI47
Study First Received: April 11, 2007
Last Updated: September 8, 2014
Health Authority: Belgium: Institutional Review Board

Keywords provided by Vrije Universiteit Brussel:
early breast cancer
post-operative radiation treatment

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

ClinicalTrials.gov processed this record on October 29, 2014