Trial of Tomotherapy in Breast Cancer (TomoBreast)

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.

Study Overview

• Status: Unknown
• Conditions: Breast Neoplasms
• Intervention / Treatment: Radiation: Conventional radiotherapy; Radiation: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Oncologisch Centrum, UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: Arm II, Short schedule, Helical Tomotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in pulmonary function and heart function tests	Assessment by pulmonary function tests and by heart echocardiography, compared with test values prior to treatment	From end of treatment up to 3 years after treatment

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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. doi: 10.1093/jnci/94.15.1143.
• 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. doi: 10.1016/s0167-8140(03)00234-2.
• 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. doi: 10.1016/j.radonc.2003.10.015.
• Versmessen H, Vinh-Hung V, Van Parijs H, Miedema G, Voordeckers M, Adriaenssens N, Storme G, De Ridder M. Health-related quality of life in survivors of stage I-II breast cancer: randomized trial of post-operative conventional radiotherapy and hypofractionated tomotherapy. BMC Cancer. 2012 Oct 25;12:495. doi: 10.1186/1471-2407-12-495.
• Van Parijs H, Miedema G, Vinh-Hung V, Verbanck S, Adriaenssens N, Kerkhove D, Reynders T, Schuermans D, Leysen K, Hanon S, Van Camp G, Vincken W, Storme G, Verellen D, De Ridder M. Short course radiotherapy with simultaneous integrated boost for stage I-II breast cancer, early toxicities of a randomized clinical trial. Radiat Oncol. 2012 Jun 1;7:80. doi: 10.1186/1748-717X-7-80.
• Adriaenssens N, De Ridder M, Lievens P, Van Parijs H, Vanhoeij M, Miedema G, Voordeckers M, Versmessen H, Storme G, Lamote J, Pauwels S, Vinh-Hung V. Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy. World J Surg Oncol. 2012 May 16;10:86. doi: 10.1186/1477-7819-10-86.
• Adriaenssens N, Vinh-Hung V, Miedema G, Versmessen H, Lamote J, Vanhoeij M, Lievens P, van Parijs H, Storme G, Voordeckers M, De Ridder M. Early contralateral shoulder-arm morbidity in breast cancer patients enrolled in a randomized trial of post-surgery radiation therapy. Breast Cancer (Auckl). 2012;6:79-93. doi: 10.4137/BCBCR.S9362. Epub 2012 Jul 30.
• Verbanck S, Hanon S, Schuermans D, Van Parijs H, Vinh-Hung V, Miedema G, Verellen D, Storme G, Vanhoeij M, Lamote J, De Ridder M, Vincken W. Small airways function in breast cancer patients before and after radiotherapy. Breast Cancer Res Treat. 2012 Oct;135(3):857-65. doi: 10.1007/s10549-012-2201-7. Epub 2012 Aug 22.
• Van Parijs H, Vinh-Hung V, Fontaine C, Storme G, Verschraegen C, Nguyen DM, Adriaenssens N, Nguyen NP, Gorobets O, De Ridder M. Cardiopulmonary-related patient-reported outcomes in a randomized clinical trial of radiation therapy for breast cancer. BMC Cancer. 2021 Nov 4;21(1):1177. doi: 10.1186/s12885-021-08916-z.

Study record dates

Study Major Dates

• Study Start: May 1, 2007
• Primary Completion (Actual): August 1, 2011
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 11, 2007
• First Submitted That Met QC Criteria: April 11, 2007
• First Posted (Estimate): April 12, 2007

Study Record Updates

• Last Update Posted (Actual): May 16, 2017
• Last Update Submitted That Met QC Criteria: May 12, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: early breast cancer; post-operative radiation treatment
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2007/009; 2007-002025-69 (EudraCT Number); SCIE2006-30 (Other Grant/Funding Number: Stichting tegen Kanker); ANI47 (Other Identifier: VUB)