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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3DCRT | Active Comparator | 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. |
|
| IMRT (Intensity modulated radiotherapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3DCRT | Radiation | conventional radiotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 3-year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jong Hoon Lee, MD | Contact | 010-8607-1269 | 001 | koppul@catholic.ac.kr |
| Yukang Kwak, MD | Contact | 010-8607-1269 | 001 | koppul@catholic.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jong Hoon Lee, MD | St. Vincent's Hospital, The Catholic University of Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent Hospital | Recruiting | Suwon | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22580119 | Result | Capelle L, Warkentin H, Mackenzie M, Joseph K, Gabos Z, Pervez N, Tankel K, Chafe S, Amanie J, Ghosh S, Parliament M, Abdulkarim B. Skin-sparing helical tomotherapy vs 3D-conformal radiotherapy for adjuvant breast radiotherapy: in vivo skin dosimetry study. Int J Radiat Oncol Biol Phys. 2012 Aug 1;83(5):e583-90. doi: 10.1016/j.ijrobp.2012.01.086. Epub 2012 May 12. | |
| 32980384 |
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| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Choi KH, Ahn SJ, Jeong JU, Yu M, Kim JH, Jeong BK, Lee JH, Kim SH, Lee JH. Postoperative radiotherapy with intensity-modulated radiation therapy versus 3-dimensional conformal radiotherapy in early breast cancer: A randomized clinical trial of KROG 15-03. Radiother Oncol. 2021 Jan;154:179-186. doi: 10.1016/j.radonc.2020.09.043. Epub 2020 Sep 24. |