Hypofractionated Vs Conventional Fractionated Radiotherapy After Breast Conserving Surgery

July 17, 2019 updated by: Xiaoli Yu, Fudan University

Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast Conserving Surgery：a Multi-center Phase III Randomized Clinical Trial

The study was designed to investigate whether hypofractionated radiotherapy(HF-RT) is noninferior to conventionally fractionated radiotherapy (CF-RT) in terms of tumor loco-regional control for patients after breast conserving surgery

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Eligible patients after breast conserving surgery will be randomized 1:1 into hypofractionated radiotherapy (HF-RT) group or conventionally fractionated radiotherapy (CF-RT) group.

Patients in HF-RT group will receive 40 Gy/15 fractions irradiation to the whole breast with/without regional lymphnodes within 3 weeks and the tumor bed is boosted to 48 Gy/15 fractions simutaneously.

Patients in CF-RT group will receive 50 Gy/ 25 fractions irradiation to whole breast with/without regional lymphnodes within 5 weeks and the tumor bed is boosted to 60 Gy/30 fractions sequentially.

The primary endpoint is loco-regional recurrence. Other cancer related events and acute/late radiation morbidities will also be evaluated. The patients will be followed for 10 years.

It is hypothesized that hypofractionated radiotherapy is non inferior to conventional fractionated radiotherapy in terms of tumor loco-regional control for patients after breast conserving surgery.

Study Type

Interventional

Enrollment (Anticipated)

4052

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Not yet recruiting
        • Guizhou Provincial People's Hospital
        • Contact:
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Recruiting
        • Suzhou Municipal Hospital
        • Contact:
          • Qunchao Hu, PhD
          • Phone Number: +86-17712679728
          • Email: hqc82@163.com
    • Liaoning
      • Dalian, Liaoning, China, 116044
        • Not yet recruiting
        • The Second Hospital of Dalian Medical University
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Fudan University Shanghai Cancer Center
        • Contact:
        • Contact:
      • Shanghai, Shanghai, China, 200002
        • Recruiting
        • Shanghai Huangpu District Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female
  • Age18-70 years
  • Imaging examination confirmed single lesion. if the tumor is multiple, it needs to be removed by single quadrantectomy
  • Receive breast conserving surgery with negative margins
  • Axillary lymph nodes treatment: Sentinel lymph node biopsy or level I/II axillary lymph node dissection. If the sentinel lymph node is negative, the axillary lymph node dissection can be omitted. If it is positive, level I/II axillary lymph node dissection with or more than 10 lymph nodes is needed.
  • The tumor bed is labeled with clips and it can be drawn on the treatment planning system.
  • Pathologically confirmed invasive breast cancer
  • Pathologically stage is T1-3N0-3M0
  • Immunohistochemical examination is conducted to determine the status of ER, PR, HER2, Ki67 after surgery
  • No distant metastases
  • No supraclavicular or internal mammary nodes metastases
  • No neoadjuvant chemotherapy
  • Fit for postoperative radiotherapy. No contraindications to radiotherapy
  • KPS≥80
  • Signed informed consent

Exclusion Criteria:

  • T4 or M1 breast cancer
  • Supraclavicular or internal mammary nodes metastases
  • Pathologically confirmed DCIS only without an invasive component
  • Bilateral breast cancer or historically confirmed contralateral invasive breast cancer
  • Treated with neoadjuvant chemotherapy or neoadjuvant endocrine therapy
  • Multiple lesions can not be removed by single quadrantectomy
  • Suspicious unresected and microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast)
  • KPS ≤ 70
  • Patients with severe non-malignant comorbidity in cardiovascular or respiration system
  • Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin
  • Previous radiotherapy to the chest wall or regional lymph node areas
  • Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis
  • Pregnant or lactating
  • Conditions indicating that the patient cannot go through the radiation therapy or follow up
  • Unable or unwilling to sign informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hypofractionated Radiotherapy

40 Gy/15 fractions irradiation is delivered to the whole breast, 2.67 Gy per fraction, 5 fractions weekly.

Tumor bed is boosted to 48 Gy simultaneously, 3.2 Gy per fraction, 5 fractions weekly.
Radiation: Hypofractionated Radiotherapy
daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
Other Names:
  • Experimental Arm
Active Comparator: Conventional Irradiation

50 Gy/25 fractions irradiation is delivered to the whole breast, 2 Gy per fraction, 5 fractions weekly.

Additional 10 Gy/5 fractions is boosted to tumor bed sequentially, 2 Gy per fraction, 5 fractions weekly.
Radiation: Conventional fractionated Radiotherapy
daily fractions, 2 Gy per fraction, five fractions per week
Other Names:
  • Standard Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Loco-regional recurrence (LRR)
Time Frame: 5 years
Defined as any clinical and biopsy-proven tumor recurrence involving the ipsilateral chest wall and/or regional nodes (including axillary, supraclavicular, infraclavicular, or internal mammary nodes).
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distant metastasis free survival (DMFS)
Time Frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Distant metastasis is defined as clinical detection of metastatic disease beyond the chest wall and/or regional lymph nodes or death or last visit. Distant metastasis free survival (DMFS) is defined as the interval starting from the date of randomization until to the event.
every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Disease free survival (DFS)
Time Frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Defined as the interval from the date of randomization to any disease recurrence or death or last visit.
every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Overall survival (OS)
Time Frame: every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Defined as the interval from the date of randomization to death or last visit.
every 3 months during the first 2 years after the last fraction received, every 6 months during 3-5 years, every year during 6-10 years
Number of patients with radiation-induced acute toxicity assesses by CTCAE4.03
Time Frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished
Acute toxicity (development of radiation dermatitis, pruritus, pain, radiation esophagitis, and radiation pneumonitis) will be assessed according to toxicity criteria of CTCAE version 4.03 before treatment, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group), 2 weeks and 3 months after the last fraction received.
before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation, 2 weeks and 3 months after the irradiation finished
Number of patients with radiation-induced late toxicity assesses by CTCAE4.03
Time Frame: before treatment, every year after the last fraction received through 10 years
Late toxicity (change of skin in irradiated area，impaired shoulder movement ，impaired shoulder movement, brachial plexopathy,ischemic heart disease) will be assessed according to toxicity criteria of CTCAE version 4.03
before treatment, every year after the last fraction received through 10 years
Number of patients with radiation-induced late toxicity assesses by LENT-SOMA Toxicity Assessment
Time Frame: before treatment, every year after the last fraction received through 10 years
Development of dyspigmentation, telangiectasia in irradiated area and radiation pulmonary fibrosis will be assessed according to toxicity criteria of LENT-SOMA
before treatment, every year after the last fraction received through 10 years
Harvard/NSABP/RTOG Breast Cosmesis Grades of patients
Time Frame: before treatment, every year after the last fraction received through 10 years
The cosmetic outcomes will be evaluated by radiation oncologists, nurses and patients using digital photographs and Harvard/NSABP/RTOG Breast Cosmesis Grading Scale. Harvard/NSABP/RTOG Breast Cosmesis Grading Scale classifies the overall aesthetic results in four categories from excellent, good, fair to poor.
before treatment, every year after the last fraction received through 10 years
Quality of Life Score assessed by EORTC-QLQ-C30 (version 3)
Time Frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years
Patients' quality of life will be assessed using self-administered questionnaire EORTC-QLQ-C30 (version 3)
before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation，every year after the treatment finished through 10 years
Quality of Life Score assessed by EORTC breast-cancer module (BR23)
Time Frame: before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years
Patients' quality of life will be assessed using self-administered questionnaire EORTC breast-cancer module (BR23)
before treatment, after 15 fractions (HF-RTgroup) or 30 fractions (CF-RT group) irradiation, every year after the last fraction received through 10 years
Number and percentage of peripheral blood lymphocytes
Time Frame: before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation
peripheral blood lymphocytes will be assessed before, during treatment (after 8 fractions irradiation for HF-RTgroup and 15 fractions for CF-RT group) and the end of treatment (15 fractions irradiation for HF-RTgroup and 30 fractions for CF-RT group). The number and percentage of peripheral blood lymphocytes will be assessed the correlation with the grade of acute toxicity assessed by CTCAE 4.03
before treatment, after 8 fractions (HF-RTgroup) and 15 fractions (CF-RT and HF-RT groups) and 30 fractions（CF-RT group) irradiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

  • Principal Investigator: Xiaoli Yu, MD, PhD, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2018

Primary Completion (Anticipated)

June 30, 2023

Study Completion (Anticipated)

June 30, 2028

Study Registration Dates

First Submitted

July 6, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FDRT-BC007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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