3DCRT vs. IMRT in Early Breast Cancer

Jong Hoon Lee690 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

690

Conditions

Radiation Toxicity

Interventions

3DCRTRADIATION

conventional radiotherapy

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

St. Vincent Hospital

Suwon, South Korea

RECRUITING

Outcomes

Primary Outcomes

Disease-free survival

Time frame: 3-year

Secondary Outcomes

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.

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.

Central Contacts

Jong Hoon Lee, MD

CONTACT

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

Yukang Kwak, MD

CONTACT

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

Data from ClinicalTrials.gov

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