Breast Cancer Clinical Trial
Official title:
RapidPlan Models Establishment for Node-Positive Breast Cancer Treated With Hypofractionation Using Edge/Truebeam
The purpose of this trial is to establish a feasible DVH estimation model of integrated IMRT plan for HF-RNI with Eclipse™ Treatment Planning System and a Varian RapidPlan™ model based on the above DVH constraints.
Status | Recruiting |
Enrollment | 195 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Aged 18-75 years old - Ipsilateral clinically diagnosed and histologically confirmed invasive breast cancer pT1-3 - =1 pathologically positive axillary lymph nodes - Karnofsky Performance Status scoring =80 - Surgery wound healed without infection - Anticipative overall survival >5 years - 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 form Exclusion Criteria: - Axillary dissection of less than 10 lymph nodes - Pathologically positive ipsilateral supraclavicular lymph node - Pathologically or radiologically confirmed positive ipsilateral internal mammary lymph nodes - Pregnant or lactating women - Treated with breast reconstruction surgery - 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 RT 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 |
Country | Name | City | State |
---|---|---|---|
China | Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | =Grade 2 acute radiation-induced toxicity | Within time from beginning of radiotherapy to 6 months after completion of radiotherapy, any acute radiation-induced toxicity will be assessed every week during radiotherapy, 4 weeks, 3 months and 6 months after the last fraction received using the (Common Terminology Criteria for Adverse Events) CTCAE 3.0 and recorded. | 6 months | |
Secondary | =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 every 6 months during the first 2 years and annually thereafter using the 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 time from the date of randomization to 5 years after completion of radiotherapy, the cosmetic outcomes will be evaluated before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter. The cosmetic outcomes are evaluated based on the Allegheny General Modification of the Harvard/(National Surgical Adjuvant Breast and Bowel Project) NSABP/ (Radiation Therapy Oncology Group) 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 | Quality of Life-EORTC QLQ-C30 and QLQ-BR23 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30 and QLQ-BR23. | 1 years | |
Secondary | Quality of Life-EORTC QLQ-C30 and QLQ-BR23 | The time from the date of randomization to 5 years after completion of radiotherapy, Quality of life will be assessed before radiotherapy, every week during radiotherapy, 4 weeks after the last fraction received, every 6 months during the first 2 years and annually thereafter using self-administered questionnaire EORTC QLQ-C30 and QLQ-BR23. | 5 years | |
Secondary | Locoregional recurrence (LRR) | 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 randomization to any recurrence of tumor at distant sites or death from any cause. | 5 years | |
Secondary | invasive recurrence free survival (IRFI) | The time from the date of randomization to any invasive recurrence of tumor or death from any cause. | 5 years | |
Secondary | overall survival (OS) | The time from the date of randomization to the date of death from any cause | 5 years |
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