3DCRT vs. IMRT in Early Breast Cancer

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02440191

Enrollment

690

Registered

2015-05-12

Start date

2015-05-31

Completion date

2018-04-30

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Radiation Toxicity

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.

Interventions

RADIATION3DCRT

conventional radiotherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame
Disease-free survival	3-year

Secondary

Measure	Time frame	Description
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.

Countries

South Korea

Contacts

Primary ContactJong Hoon Lee, MD

koppul@catholic.ac.kr010-8607-1269

Backup ContactYukang Kwak, MD