Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
118 participants
INTERVENTIONAL
2007-05-31
2017-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Conventional radiotherapy
Conventional Long schedule Radiotherapy Arm
Conventional radiotherapy
Radiation treatment delivered by conventional linear accelerator using matching fields
Tomotherapy
Short course schedule by tomotherapy
Tomotherapy
CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy or lactation
* Fertile patients without effective contraception
* Psychiatric or addictive disorders
18 Years
FEMALE
No
Sponsors
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Vrije Universiteit Brussel
OTHER
Responsible Party
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Vincent Vinh-Hung, MD, PhD
Clinical Professor
Principal Investigators
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Mark De Ridder, MD, PhD
Role: STUDY_DIRECTOR
Radiotherapy Department, Universitair Ziekenhuis Brussel
Vincent Vinh-Hung, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Radiotherapy-Oncology, Universitair Ziekenhuis Brussel
Locations
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Oncologisch Centrum, UZ Brussel
Jette, Brussels Capital, Belgium
Countries
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References
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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.
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.
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, Cecilia-Joseph E, Gorobets O, Storme G, Adriaenssens N, Heyndrickx B, Verschraegen C, Nguyen NP, De Ridder M, Vinh-Hung V. Lung-heart toxicity in a randomized clinical trial of hypofractionated image guided radiation therapy for breast cancer. Front Oncol. 2023 Nov 20;13:1211544. doi: 10.3389/fonc.2023.1211544. eCollection 2023.
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.
Other Identifiers
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2007-002025-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SCIE2006-30
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
ANI47
Identifier Type: OTHER
Identifier Source: secondary_id
2007/009
Identifier Type: -
Identifier Source: org_study_id
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