Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
690 participants
INTERVENTIONAL
2015-05-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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3DCRT
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.
3DCRT
conventional radiotherapy
IMRT (Intensity modulated radiotherapy)
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.
3DCRT
conventional radiotherapy
Interventions
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3DCRT
conventional radiotherapy
Eligibility Criteria
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Inclusion Criteria
2. pT1-2N0
3. no evidence of distant metastasis
4. no previous malignancy
5. patient age, 20 - 80 years
6. Karnofsky performance score ≥ 70
7. adequate bone marrow, liver, and renal function (leucocytes \> 4,000/mm3, hemoglobin \> 10 g/dL, platelets \> 100,000/mm3; serum bilirubin \< 1.5 mg/dL, serum transaminase \< 2.5 times the upper normal limit; serum creatinine \< 1.5 mg/dL).
8. completion of scheduled chemotherapy
Exclusion Criteria
2. distant metastasis
3. mastectomy
4. male
5. both breast cancer
20 Years
75 Years
ALL
Yes
Sponsors
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Jong Hoon Lee
OTHER
Responsible Party
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Jong Hoon Lee
Professor
Principal Investigators
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Jong Hoon Lee, MD
Role: PRINCIPAL_INVESTIGATOR
St. Vincent's Hospital, The Catholic University of Korea
Locations
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St. Vincent Hospital
Suwon, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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KROG 15-03
Identifier Type: -
Identifier Source: org_study_id
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