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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-002025-69 | EudraCT Number | ||
| SCIE2006-30 | Other Grant/Funding Number | Stichting tegen Kanker | |
| ANI47 | Other Identifier | VUB |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional radiotherapy | Active Comparator | Conventional Long schedule Radiotherapy Arm |
|
| Tomotherapy | Experimental | Short course schedule by tomotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional radiotherapy | Radiation | Radiation treatment delivered by conventional linear accelerator using matching fields |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark De Ridder, MD, PhD | Radiotherapy Department, Universitair Ziekenhuis Brussel | Study Director |
| Vincent Vinh-Hung, MD, PhD | Radiotherapy-Oncology, Universitair Ziekenhuis Brussel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oncologisch Centrum, UZ Brussel | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 13129629 | Background | 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. | |
| 15064006 | Background | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D050397 | Radiotherapy, Intensity-Modulated |
| ID | Term |
|---|---|
| D020266 | Radiotherapy, Conformal |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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| Tomotherapy | Radiation | CT image guided intensity modulated radiation therapy delivered by the Tomotherapy HiArt system |
|
|
| 12165639 | Background | 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. |
| 23098579 | Result | 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. |
| 22656865 | Result | 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. |
| 22591589 | Result | 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. |
| 22904635 | Result | 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. |
| 22910929 | Result | 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. |
| 38053657 | Derived | 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. |
| 34736429 | Derived | 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. |
| D017437 |
| Skin and Connective Tissue Diseases |