Back to resultsAdjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer (ARROW)
Primary Purpose
Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
External Beam radiotherapy using IMRT technique
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring regional nodal irradiation, IMRT, Hypofractionated radiotherapy for one week
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years old
- Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)
- Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer pT1-3
- >=1 pathologically positive axillary lymph nodes
- Karnofsky Performance Status scoring ≥80, and anticipative overall survival >5 years
- Surgery wound healed without infection
- Pathologically surgical margin >2mm
- ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
- Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
- Ability to understand and willingness to participate the research and sign the consent forms
Exclusion Criteria:
- Pathologically positive ipsilateral supraclavicular lymph node
- Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
- Pregnant or lactating women
- Severe non-neoplastic medical comorbidities
- History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin and carcinoma in situ of the cervix
- simultaneous contralateral breast cancer
- Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
- Active collagen vascular disease
- Definitive pathological or radiologic evidence of distant metastatic disease
- Primary T4 tumor
- Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
Sites / Locations
- Ruijin Hospital, Shanghai Jiaotong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hypofractionated radiotherapy
Arm Description
Patients with an indication for regional nodal irradiation will receive 5.2 Gy in 5 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk) and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast.
Outcomes
Primary Outcome Measures
Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity
Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicities will be assessed and recorded after the last fraction using the Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
Secondary Outcome Measures
Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity
Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 3.0
Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale
The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast
Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale
The cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast
Locoregional recurrence
any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area(including supraclavicular, infraclavicular or internal mammary lymph nodes)
Distant metastasis free survival (DMFS)
The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause
Invasive recurrence-free survival (IRFS)
The time from the date of enrollment to any invasive recurrence of tumor or death from any cause
Over survival (OS)
The time from the date of enrollment to the date of death from any cause
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04509648
Brief Title
Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer
Acronym
ARROW
Official Title
One-week Hypofractionated Radiotherapy in Breast Cancer Patients With an Indication for Regional Nodal Irradiation: Prospective, Single-arm Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this trial is to investigate the toxicities and efficacy of hypofractionated regional nodal radiotherapy (RNI) for one week in breast cancer patients treated with mastectomy or breast conserving surgery. Hypofractionated radiotherapy will be delivered to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). Eligible breast cancer patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicities, locoregional recurrence, over survival, distant metastasis, and quality of life.
Detailed Description
Eligible breast cancer patients will receive hypofractionated radiotherapy of 5.2 Gy in 5 fractions within one week and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast. The dose is prescribed to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk). All patients are treated with intensity modulated radiation therapy (IMRT) technique. The primary endpoint is ≥2 grade any acute radiation induced toxicity event. patients will be followed for at least 1 years to evaluate the acute and late radiation-induced toxicity, locoregional recurrence, over survival, distant metastasis, and quality of life.
Calculation of the required number of cases based on an alpha of 0.05 and a power of 80% with a maximal tolerable toxicity difference of 10% during and within 6 months after RNI comparing to conventional radiotherapy and lost rate of follow up of 10%. In total 197 patients are needed to be recruited.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
regional nodal irradiation, IMRT, Hypofractionated radiotherapy for one week
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
197 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hypofractionated radiotherapy
Arm Type
Experimental
Arm Description
Patients with an indication for regional nodal irradiation will receive 5.2 Gy in 5 fractions to chest wall or whole breast and regional lymph regions (including supraclavicular/infraclavicular region, internal mammary nodes, and any part of the axillary bed at risk) and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast.
Intervention Type
Radiation
Intervention Name(s)
External Beam radiotherapy using IMRT technique
Intervention Description
2600cGy/ 5 fractions / 1 weeks to ipsilateral chest wall or whole breast and regional lymph regions and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast
Primary Outcome Measure Information:
Title
Cumulative complication rate of ≥Grade 2 Acute Radiation-induced Toxicity
Description
Within time from the beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicities will be assessed and recorded after the last fraction using the Common Terminology Criteria for Adverse Events (CTCAE) 3.0.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Cumulative complication rate of ≥Grade 2 Late Radiation-induced Toxicity
Description
Within time from 6 months after completion of radiotherapy to 5 years after completion of radiotherapy, any late toxicity will be assessed and recorded using the Radiation Therapy Oncology Group (RTOG) /European Organization for Research on Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring Schema and CTCAE 3.0
Time Frame
5 years
Title
Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale
Description
The cosmetic outcomes will be evaluated at 6 months after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast
Time Frame
6 months
Title
Number of Participants with excellent or good Cosmetic outcomes following breast conserving surgery-Harvard/ NSABP/RTOG scoring scale
Description
The cosmetic outcomes will be evaluated at 5 years after last fractions. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/National Surgical Adjuvant Breast and Bowel Project (NSABP)/ RTOG scoring scale which graded patients into the following four classifications: excellent, when compared to the untreated breast, there is a minimal or no difference in the size or shape of the treated breast; good, slight difference in the size or shape of the treated breast; fair, obvious difference in the size or shape of the treated breast; and poor, marked change in the size or shape of the treated breast
Time Frame
5 years
Title
Locoregional recurrence
Description
any first recurrence confirmed by histology or cytology within the ipsilateral chest wall and/or regional nodes area(including supraclavicular, infraclavicular or internal mammary lymph nodes)
Time Frame
5 years
Title
Distant metastasis free survival (DMFS)
Description
The time from the date of enrollment to any recurrence of tumor at distant sites or death from any cause
Time Frame
5 years
Title
Invasive recurrence-free survival (IRFS)
Description
The time from the date of enrollment to any invasive recurrence of tumor or death from any cause
Time Frame
5 years
Title
Over survival (OS)
Description
The time from the date of enrollment to the date of death from any cause
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Quality of Life-EORTC QLQ-C30
Description
Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30
Time Frame
6 months
Title
Quality of Life-EORTC BR-23
Description
Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23
Time Frame
6 months
Title
Quality of Life-EORTC QLQ-C30
Description
Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-C30
Time Frame
5 years
Title
Quality of Life-EORTC BR-23
Description
Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-BR23
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged >18 years old
Underwent radical surgery with either mastectomy or breast conserving surgery and axillary lymph node dissection (ALND)
Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer T1-3
>=1 pathologically positive axillary lymph nodes
Karnofsky Performance Status scoring ≥80, and anticipative overall survival >5 years
Surgery wound healed without infection
Negative pathologically surgical margin
ER (estrogen-receptor), PR (progesterone-receptor), HER2 (human epidermal growth factor receptor 2) and Ki67 testing can be performed on the primary breast tumor
Women of child-bearing potential must agree to use adequate contraception for up to 1 month before study treatment and the duration of study participation
Ability to understand and willingness to participate the research and sign the consent forms
Exclusion Criteria:
Pathologically positive ipsilateral supraclavicular lymph node
Pathologically or radiologically confirmed involvement of ipsilateral internal mammary lymph nodes
Pregnant or lactating women
Severe non-neoplastic medical comorbidities
History of non-breast malignancy within 5 years with the exception of lobular carcinoma in situ, basal cell carcinoma of the skin, carcinoma in situ of skin, Adenocarcinoma in situ of the lung and carcinoma in situ of the cervix
simultaneous contralateral breast cancer
Previous radiotherapy to the neck, chest and/or ipsilateral axillary region
Active collagen vascular disease
Definitive pathological or radiologic evidence of distant metastatic disease
Primary T4 tumor
Interval between radical surgery (mastectomy or breast conserving surgery) and radiotherapy was more than 12 weeks or interval between last dose of adjuvant chemotherapy and radiotherapy was more than 8 weeks
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lu Cao, MD
Phone
+86-021-64370045
Ext
602400
Email
caolu_163@ymail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lu Cao, MD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Cao, MD, PhD
Phone
+86-021-64370045
Ext
602400
Email
caolu_163@ymail.com
First Name & Middle Initial & Last Name & Degree
Jia-Yi Chen, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer
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