---
title: 3DCRT vs. IMRT in Early Breast Cancer
nct_id: NCT02440191
overall_status: UNKNOWN
phase: PHASE3
sponsor: Jong Hoon Lee
study_type: INTERVENTIONAL
primary_condition: Radiation Toxicity
countries: South Korea
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02440191.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02440191"
ct_last_update_post_date: 2017-06-05
last_seen_at: "2026-05-12T06:52:17.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 3DCRT vs. IMRT in Early Breast Cancer

**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

**NCT ID:** [NCT02440191](https://clinicaltrials.gov/study/NCT02440191)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 690
- **Lead Sponsor:** Jong Hoon Lee
- **Conditions:** Radiation Toxicity
- **Start Date:** 2015-05
- **Completion Date:** 2018-04
- **CT.gov Last Update:** 2017-06-05

## 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.

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
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
```

## Arms

- **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.

## Interventions

- **3DCRT** (RADIATION) — conventional radiotherapy

## Primary Outcomes

- **Disease-free survival** _(time frame: 3-year)_

## Secondary Outcomes

- **Toxicity** _(time frame: 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.)_

## Locations (1)

- St. Vincent Hospital, Suwon, South Korea — _RECRUITING_

## Recent Field Changes (last 30 days)

- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.st. vincent hospital|suwon||south korea` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02440191*  
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