Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional radiotherapy | Radiation | — | UNRESOLVED |
| Tomotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Conventional radiotherapy
- description
- Conventional Long schedule Radiotherapy Arm
- interventionNames
- Radiation: Conventional radiotherapy
- type
- EXPERIMENTAL
- label
- Tomotherapy
- description
- Short course schedule by tomotherapy
- interventionNames
- Radiation: Tomotherapy
Primary outcomes (1)
- measure
- Change from baseline in pulmonary function and heart function tests
- timeFrame
- From end of treatment up to 3 years after treatment
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDVoordeckers 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. PMID 13129629
- BACKGROUNDVoordeckers 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. PMID 15064006
- BACKGROUNDWhelan 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. PMID 12165639
- RESULTVersmessen 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. PMID 23098579
- RESULTVan 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. PMID 22656865
- RESULTAdriaenssens 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.