Adjuvant Regional Nodal Radiation Therapy for One Week in Breast Cancer

Breast Cancer Clinical Trial

— ARROW  

Official title:

One-week Hypofractionated Radiotherapy in Breast Cancer Patients With an Indication for Regional Nodal Irradiation: Prospective, Single-arm Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04509648
• Other study ID #: RJBC-SHF RNI
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 30, 2026

Study information

• Verified date: March 2023
• Source: Ruijin Hospital
• Contact: Lu Cao, MD
• Phone: +86-021-64370045
• Email: caolu_163[@]ymail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 197
• Est. completion date: December 30, 2026
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• External Beam radiotherapy using IMRT technique
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

Locations

Country	Name	City	State
China	Ruijin Hospital, Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-C30	6 months
Other	Quality of Life-EORTC BR-23	Quality of life will be assessed before radiotherapy and 6 months after last fractions using self administered questionnaire EORTC QLQ-BR23	6 months
Other	Quality of Life-EORTC QLQ-C30	Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-C30	5 years
Other	Quality of Life-EORTC BR-23	Quality of life will be assessed before radiotherapy and 5 years after last fractions using self administered questionnaire EORTC QLQ-BR23	5 years
Primary	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.	6 months
Secondary	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	5 years
Secondary	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	6 months
Secondary	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	5 years
Secondary	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)	5 years
Secondary	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	5 years
Secondary	Invasive recurrence-free survival (IRFS)	The time from the date of enrollment to any invasive recurrence of tumor or death from any cause	5 years
Secondary	Over survival (OS)	The time from the date of enrollment to the date of death from any cause	5 years