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Radiation ToxicityPhase 3NCT02440191

3DCRT vs. IMRT in Early Breast Cancer

A Phase 3 study testing 3DCRT in people with Radiation Toxicity, run by Jong Hoon Lee at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Radiation Toxicity
What is being tested?
3DCRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
690 participants
Where
1 siteSouth Korea
Study dates
May 2015to Apr 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Jong Hoon Lee, MD contact

010-8607-1269 ext. 001

koppul@catholic.ac.kr

Yukang Kwak, MD contact

010-8607-1269 ext. 001

koppul@catholic.ac.kr

South Korea1 site, 1 recruiting

  • St. Vincent Hospital

    Suwon

    Jong Hoon Lee, MD, koppul@catholic.ac.kr

    Recruiting

Other trials in South Korea

About this study

Official title: Postoperative Radiotherapy With Intensity-modulated Radiation Therapy (IMRT) Using Simultaneous Integrated Boost Versus 3-dimensional Conformal Radiotherapy (3D-CRT) in Early Breast Cancer: a Prospective Randomized Trial

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.

Read the detailed description

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.

Being tested
3DCRT
Medical subject headings
Radiation Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 3DCRTRadiation

    conventional radiotherapy

Study groups in NCT02440191
Study groupRoleWhat they receive
3DCRTActive comparatorconventional 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.
Receives: Radiation: 3DCRT
IMRT (Intensity modulated radiotherapy)ExperimentalIntensity-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.
Receives: Radiation: 3DCRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Disease-free survival

    Measured: 3-year

Secondary outcomes (1)

  1. 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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionApr 2018 (estimated)
  4. Study completionApr 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
690 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02440191
Sponsor's protocol ID
KROG 15-03
Status last verified
Jun 2017
First submitted
28 Apr 2015
Last updated
5 Jun 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • 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.

    PubMed 22580119

  • 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.

    PubMed 32980384

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing 3DCRT in people with Radiation Toxicity, run by Jong Hoon Lee at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jong Hoon Lee, MD (010-8607-1269 ext. 001, koppul@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free survival (time frame: 3-year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02440191, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2017.

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