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

April 11, 2007
September 8, 2014
May 2007
August 2011   (final data collection date for primary outcome measure)
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
Pulmonary and cardiac toxicities determined by medical imaging and functional tests.
Complete list of historical versions of study NCT00459628 on ClinicalTrials.gov Archive Site
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.
Local-regional recurrences.
Not Provided
Not Provided
 
Trial of Tomotherapy in Breast Cancer
Randomized Trial Comparing Conventional vs Short-course Reduced Volume Conformal Post-surgery Radiation Treatment in Women With Stage I or II Breast Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasms
  • Radiation: Conventional radiotherapy
    Radiation treatment delivered by conventional linear accelerator using matching fields
    Other Name: Arm I, Long schedule
  • Radiation: Tomotherapy
    CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
    Other Name: Arm II, Short schedule, Helical Tomotherapy
  • Active Comparator: Conventional radiotherapy
    Conventional Long schedule Radiotherapy Arm
    Intervention: Radiation: Conventional radiotherapy
  • Experimental: Tomotherapy
    Short course schedule by tomotherapy
    Intervention: Radiation: Tomotherapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
December 2016
August 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00459628
2007/009, 2007-002025-69, SCIE2006-30, ANI47
Yes
Vincent Vinh-Hung, MD, PhD, Vrije Universiteit Brussel
Vrije Universiteit Brussel
Not Provided
Study Director: Mark De Ridder, MD, PhD Radiotherapy Department, Universitair Ziekenhuis Brussel
Principal Investigator: Vincent Vinh-Hung, MD, PhD Radiotherapy-Oncology, Universitair Ziekenhuis Brussel
Vrije Universiteit Brussel
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP