3DCRT vs. IMRT in Early Breast Cancer

Phase 3

• Conditions: Radiation Toxicity
• Interventions: Radiation: 3DCRT

• Registration Number: NCT02440191
• Lead Sponsor: Jong Hoon Lee

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.

Study Timeline

• Study First Submitted: 2015-04-28
• Study Start: 2015-05
• Study First Submitted QC: 2015-05-06
• Study First Posted: 2015-05-12
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-01
• Last Update Posted: 2017-06-05
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 690

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3DCRT	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.
IMRT (Intensity modulated radiotherapy)	3DCRT	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.

Primary Outcome Measures

Name	Time	Method
Disease-free survival	3-year

Secondary Outcome Measures

Name	Time	Method
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.	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.

Trial Locations

Locations (1)

St. Vincent Hospital; 🇰🇷 Suwon, Korea, Republic of