临床试验雷达

Rate of any moderate-marked adverse effects

The rate of moderate to marked adverse effects in the breast or chest wall at 1 year will be measured using a questionnaire called the Clinician Assessment of Radiation-Specific Toxicity by clinican. This will be compared against historical controls. The questionnaire includes 10 items: 4 Likert-type questions and 6 yes/no questions. Items are rated from 0 to 4, with higher scores indicating more adverse effects. A "yes" response indicates the occurrence of an adverse event.

1 year

In-breast tumor recurrence

In-breast tumor recurrence at 2 years is defined according to the standard definition as the time from enrollment to any of the following events: invasive ipsilateral recurrence and/or ipsilateral DCIS recurrence. Recurrence will be measured via medical record abstraction and clinical evaluation.

2 years

Quality of life at measured by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30)

Quality of life at 12 months will be measured as defined by European Organization for Research and Treatment of Cancer ( EORTC QLQ-C30). The EORTC QLQ-C30 is a cancer-specific instrument with 30 questions that incorporates 9 multi-item scales: 5 functional scales (physical, role, cognitive, emotional, and social); 9 symptom scales (fatigue, pain, nausea and vomiting, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties); and a global health and quality-of-life scale. Most questions used 4 point scale (1 'Not at all' to 4 'Very much'); 2 questions used 7-point scale (1 'very poor' to 7 'Excellent'). The scores of these scales were averaged from the scores of the component items, transformed and analyzed on a 0 - 100 scale. A higher score=better level of functioning or greater degree of symptoms.

12 months