Trial of Tomotherapy in Breast Cancer

Breast Neoplasms Clinical Trial

— TomoBreast  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00459628
• Other study ID #: 2007/009
• Secondary ID: 2007-002025-69SC
• Status: Active, not recruiting
• Phase: N/A
• First received: April 11, 2007
• Last updated: May 12, 2017
• Start date: May 2007
• Est. completion date: December 2017

Study information

• Verified date: May 2017
• Source: Vrije Universiteit Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 118
• Est. completion date: December 2017
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Radiation:
• Conventional radiotherapy
Radiation treatment delivered by conventional linear accelerator using matching fields
• Tomotherapy
CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system

Locations

Country	Name	City	State
Belgium	Oncologisch Centrum, UZ Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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 sho — View Citation

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 — View Citation

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-I — View Citation

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; — View Citation

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 hypofractio — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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