Hypofractionated Irradiation At Regional Nodal Area for Breast Cancer Vs Existed Standard Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-21

Study Completion Date

2027-12-31

Brief Summary

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The main objective of this trial is to investigate the efficacy and safety of hypofractionated radiotherapy of 3 or 4 weeks by comparing with conventional radiotherapy of 5 or 6 weeks using intensity-modulated radiation therapy (IMRT) in breast cancer patients with an indication for regional nodal irradiation (RNI) following mastectomy or breast conserving surgery. Patients will be randomized to hypofractionated radiotherapy or conventional radiotherapy delivered to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). Eligible breast cancer patients will be followed for at least 5 years to evaluate the difference in 5-year locoregional recurrence, over survival, distant metastasis, toxicity and life quality between two groups.

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Detailed Description

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Investigators hypothesize that hypofractionated radiotherapy is equally effective and safe as conventional radiotherapy in breast cancer patients with an indication for regional nodal irradiation. Eligible breast cancer patients are randomized 1:1 into the following two groups: hypofractionated radiotherapy of 2.67 Gy for 16 fractions (and sequential tumor bed boost of 2.67 Gy for 4 fractions in patients with intact breast) and conventional radiotherapy of 2Gy for 25 fractions (and sequential tumor bed boost of 2 Gy for 5 fractions in patients with intact breast). The dose was prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes). All patients are treated with IMRT. The primary endpoint is locoregional recurrence. Patients will be followed at least 5 years after radiotherapy to evaluated over survival, distant metastasis, toxicity and life quality.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hypofractionated radiotherapy

Patients with an indication for regional nodal irradiation will received 2.67 Gy for 16 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67 Gy for 4 fractions following breast conserving surgery

Group Type EXPERIMENTAL

Hypofractionated radiotherapy

Intervention Type RADIATION

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

Conventional radiotherapy

Patients with an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.

Group Type ACTIVE_COMPARATOR

Conventional radiotherapy

Intervention Type RADIATION

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Interventions

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Hypofractionated radiotherapy

4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast

Intervention Type RADIATION

Conventional radiotherapy

5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast

Intervention Type RADIATION

Other Intervention Names

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Experimental Arm Active Comparator Arm

Eligibility Criteria

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Inclusion Criteria

* Age 18-75 years old
* unilateral histologically confirmed invasive breast carcinoma of pT1-3
* breast conservation surgery or mastectomy
* Breast reconstruction is allowed
* histologically confirmed positive axillary lymph nodes (positive sentinel lymph nodes without axillary dissection is allowed)
* Life expectancy of \>5 years
* A minimum negative surgical margin width of \>2mm
* Karnofsky Performance Status ≥80
* Estrogen-receptor, Progesterone-receptor, human epidermal growth factor receptor-2 (HER-2) and Ki67 index can be performed on the primary breast tumor or axillary nodes.
* Written informed consent

Exclusion Criteria

* Supraclavicular lymph nodes, positive ipsilateral internal mammary lymph nodes or residual axillary nodes that may be eligible for a boost dose.
* Pregnant or lactating
* Severe non-neoplastic medical comorbidities
* Diagnosis of non-breast malignancy within 5 years preceding enrollment (except for basal cell carcinoma of the skin or carcinoma in situ of the cervix).
* Simultaneous contralateral breast cancer
* Previous RT to thoracic and/or axillary, cervical region
* Active collagen vascular disease
* Evidence of distant metastatic disease and/or T4 disease

Notes for exlusion criteria:

1. Patients with severe non-neoplastic medical comorbidities (e.g.,severe ischemic heart disease, severe arrhythmia or severe chronic obstructive pulmonary disease ) that would preclude radiation treatment will be excluded.
2. Simultaneous contralateral breast cancer includes histologically confirmed DCIS only.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No