Trial reportJournal of cancer research and clinical oncology2014
Intensity-modulated and hypofractionated simultaneous integrated boost adjuvant breast radiation employing statics ports of tomotherapy (TomoDirect): a prospective phase II trial.
Trial report in Journal of cancer research and clinical oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03345420 (NOVEMBER), which is not on this map. Cited by 25 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
NOVEMBER (Novem- (9), BrEast Radiation), A Phase II Trial of a 9 Day Course of Whole Breast Radiotherapy for Early Stage Breast Cancer
Who cites it
25 citing papers in PubMed.
- Hypofractionation with simultaneous integrated boost after breast-conserving surgery: Long term results of two phase-II trials.Breast (Edinburgh, Scotland) · 2022Trial
- Neoadjuvant chemoradiotherapy delivered with helical tomotherapy under daily image guidance for rectal cancer patients: efficacy and safety in a large, multi-institutional series.Journal of cancer research and clinical oncology · 2019Trial
- Phase II trial of hypofractionated VMAT-based treatment for early stage breast cancer: 2-year toxicity and clinical results.Radiation oncology (London, England) · 2016Trial
- Comparison of adverse events between intensity-modulated radiation therapy and tomotherapy for early stage breast cancer: a retrospective cohort study.Frontiers in oncology · 2025Article
- Comparison of helical and TomoDirect techniques with simultaneous integrated boost in early breast cancer patients.Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology · 2023Article
- Adjuvant hypofractionated radiotherapy with simultaneous integrated boost after breast-conserving surgery: A systematic literature review.Translational oncology · 2022Review
- Hypofractionation and Concomitant Boost in Ductal Carcinoma In Situ (DCIS): Analysis of a Prospective Case Series with Long-Term Follow-Up.Life (Basel, Switzerland) · 2022Article
- Adjuvant radiation therapy in breast cancer: Recent advances & Indian data.The Indian journal of medical research · 2021Review
- Acute and intermediate toxicity of 3-week radiotherapy with simultaneous integrated boost using TomoDirect: prospective series of 287 early breast cancer patients.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2021Article
- Five-year survival outcomes of intensity-modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) using forward IMRT or Tomotherapy for breast cancer.Scientific reports · 2020Article
- Omission of postoperative radiation after breast conserving surgery: A progressive paradigm shift towards precision medicine.Clinical and translational radiation oncology · 2020Review
- De-escalation of breast radiotherapy after conserving surgery in low-risk early breast cancer patients.Medical oncology (Northwood, London, England) · 2018Review
- Volumetric modulated arc therapy (VMAT) to deliver nodal irradiation in breast cancer patients.Medical oncology (Northwood, London, England) · 2017Observational
- Ten-year results of accelerated hypofractionated adjuvant whole-breast radiation with concomitant boost to the lumpectomy cavity after conserving surgery for early breast cancer.Medical oncology (Northwood, London, England) · 2017Article
- Hypofractionation with no boost after breast conservation in early-stage breast cancer patients.Medical oncology (Northwood, London, England) · 2016Article
- Volumetric modulated arc therapy (VMAT) in the combined modality treatment of anal cancer patients.The British journal of radiology · 2016Article
- Setup Error and Effectiveness of Weekly Image-Guided Radiation Therapy of TomoDirect for Early Breast Cancer.Cancer research and treatment · 2015Article
- Helical and Static-port Tomotherapy Using the Newly-developed Dynamic Jaws Technology for Lung Cancer.Technology in cancer research & treatment · 2015Article
- Tangent field technique of TomoDirect improves dose distribution for whole-breast irradiation.Journal of applied clinical medical physics · 2015Article
- Use of tomotherapy in treatment of synchronous bilateral breast cancer: dosimetric comparison study.The British journal of radiology · 2015Article
Corrections and comments
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Authors and funding
13 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo report the 1-year outcomes of a prospective phase II study on hypofractionated whole-breast intensity-modulated radiotherapy (IM-WBRT) with a simultaneous integrated boost (SIB) to the tumor bed delivered with static ports of tomotherapy (TomoDirect) (TD).
methodsA prospective cohort of 82 patients was enrolled between 2011 and 2012. Treatment schedule consisted of 45 Gy/20 fractions to the whole breast and 50 Gy/20 fractions to the surgical bed delivered concomitantly with TD over 4 weeks. A one-armed optimal two-stage Simon's design was selected to test the hypothesis that treatment modality under investigation would decrease acute skin toxicity over historical data using conventional fractionation and sequential boost. Primary endpoint was acute skin toxicity. Secondary endpoints included late toxicity, cosmesis, quality of life and local control.
resultsMedian follow-up was 12 months (range 6-18). Maximum detected acute skin toxicity was G0 41 %; G1 53 %; G2 6 %; G3 <1 %. With two G2-G3 acute skin toxicity events in the first stage and four in the second, the study fulfilled the requirements for the definition of the treatment approach under investigation as promising. Late skin toxicity was mild with no >G2 events. Cosmesis was good/excellent in 91 % of patients and fair/poor in 9 %. Quality of life was preserved over time, with the exception of fatigue, which was transiently increased.
conclusionsHypofractionated IM-WBRT with a SIB to the tumor bed delivered with TD provides consistent clinical results and it is able to reduce acute skin toxicity rate over conventionally fractionated and sequential boost tomotherapy-based IM-WBRT.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.