NCT02440191

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
690

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2015

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2015

Completed
3 days until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 12, 2015

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

June 5, 2017

Status Verified

June 1, 2017

Enrollment Period

2.9 years

First QC Date

April 28, 2015

Last Update Submit

June 1, 2017

Conditions

Radiation Toxicity

Outcome Measures

Primary Outcomes (1)

  • Disease-free survival

    3-year

Secondary Outcomes (1)

  • Toxicity

    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.

Study Arms (2)

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.

Radiation: 3DCRT

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.

Radiation: 3DCRT

Interventions

3DCRTRADIATION

conventional radiotherapy

3DCRTIMRT (Intensity modulated radiotherapy)

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histologically confirmed breast cancer after breast-conserving surgery
  • pT1-2N0
  • no evidence of distant metastasis
  • no previous malignancy
  • patient age, 20 - 80 years
  • Karnofsky performance score ≥ 70
  • 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).
  • completion of scheduled chemotherapy

You may not qualify if:

  • carcinoma in situ of breast
  • distant metastasis
  • mastectomy
  • male
  • both breast cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent Hospital

Suwon, South Korea

RECRUITING

Related Publications (2)

  • 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.

    PMID: 22580119RESULT

  • 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.

    PMID: 32980384DERIVED

MeSH Terms

Conditions

Radiation Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jong Hoon Lee, MD

    St. Vincent's Hospital, The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jong Hoon Lee, MD

CONTACT

010-8607-1269koppul@catholic.ac.kr

Yukang Kwak, MD

CONTACT

010-8607-1269koppul@catholic.ac.kr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 28, 2015

First Posted

May 12, 2015

Study Start

May 1, 2015

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

June 5, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will share

Locations

KR(1)