3DCRT vs. IMRT in Early Breast Cancer

NCT ID: NCT02440191

Last Updated: 2017-06-05

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

690 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Radiation Toxicity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type ACTIVE_COMPARATOR

3DCRT

Intervention Type RADIATION

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.

Group Type EXPERIMENTAL

3DCRT

Intervention Type RADIATION

conventional radiotherapy

Interventions

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3DCRT

conventional radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

1. histologically confirmed breast cancer after breast-conserving surgery
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

1. carcinoma in situ of breast
2. distant metastasis
3. mastectomy
4. male
5. both breast cancer
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jong Hoon Lee

OTHER

Sponsor Role lead

Responsible Party

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Jong Hoon Lee

Professor

Responsibility Role SPONSOR_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jong Hoon Lee, MD

Role: CONTACT

010-8607-1269 ext. 001

Yukang Kwak, MD

Role: CONTACT

010-8607-1269 ext. 001

Facility Contacts

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Jong Hoon Lee, MD

Role: primary

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.

Reference Type RESULT
PMID: 22580119 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32980384 (View on PubMed)

Other Identifiers

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KROG 15-03

Identifier Type: -

Identifier Source: org_study_id

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