A Phase 3 interventional study of 3DCRT in Radiation Toxicity, sponsored by Jong Hoon Lee. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Jong Hoon Lee · Phase 3, Interventional, and Treatment
It has been not clinically determined whether TomoDirect was dosimetrically better than 3D-CRT for Asian patients with early breast cancer. Therefore, the objective of this study was to compare dosimetric parameters of TomoDirect and 3D-CRT in early breast cancer patients of an Asian cohort.
In breast cancer patients, helical TomoTherapy is not a suitable option since the gantry continuously rotates around the patient, and this technique can deliver low dose radiation to lungs that is associated with an occurrence of radiation pneumonitis. To avoid this inefficiency of beam usage, a TomoDirect option using static gantry positions combined with simultaneous couch translation and dynamic collimator modulation has been developed. In a pilot study, TomoDirect seemed particularly well suited for postoperative irradiation in breast cancer patients. TomoDirect achieved an optimal target volume coverage and coincident adequate normal tissue sparing in a dosimetric study. Clinical studies of TomoDirect in breast cancer patients are scarce and have been assessed only in small and retrospective series. Thus, we undertook a prospective study on the technical feasibility and toxicity of TomoDirect in breast cancer patients who received postoperative radiotherapy.
Jong Hoon Lee is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
conventional 3-dimensional conformal radiotherapy on the breast, 50.4 Gy/28 fx and tumor bed boost, 9 Gy/5 fx will be irradiated for 6.5 weeks.
Radiation: 3DCRT
Intensity-modulated radiotherapy (IMRT) with simultaneous integrated boost (SIB) on the whole breast, 50.4 Gy/28 fx and tumor bed, 57.4 Gy/28 fx will be irradiated for 5.5 weeks. Unlike 3DCRT, concomittant boost technique is used in the IMRT arm.
Radiation: 3DCRT
conventional radiotherapy
Disease-free survival
Time frame: 3-year
Toxicity
Acute toxicity within 3 months after radiotherpy and late toxicity thereafter up to 3 years will be followed up by physicians. Adverse effects of radiotherapy were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.0). Incidence of toxicity grade ≥ 2 was recorded.
Time frame: acute (time frame: with 3 months after radiation) and late (time frame: up to 3 years after radiation), Participants will be followed for an expected average of 3 years.
Plan to share: Yes
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