University Hospital of Heidelberg, Radiation Oncology 69120 Heidelberg (Baden-Württemberg) GermanyRekrutierend» Google-Maps Ansprechpartner: Jürgen Debus, Prof. Dr. Phone: +49-6221-56 Phone (ext.): 8202 E-Mail: juergen.debus@med.uni-heidelberg.de
1. Fatigue 12 weeks (Time Frame - 12 weeks): Assessment of fatigue from baseline (before treatment start) compared to 12 weeks after treatment start as assessed by the FACIT (Functional Assessment of Cancer Therapy) Fatigue Assessment Questionnaire. Scale ranges from 0 (no fatigue) to 52 (maximum fatigue).
Secondary outcome:
1. Fatigue 5 weeks, 6 months, 2 years, 5 years after treatment start (Time Frame - 5 weeks, 6 months, 2 years, 5 years after treatment start): Assessment of fatigue from baseline (before treatment start) compared to 5 weeks, 6 months, 2 years, 5 years after treatment start as assessed by the FACIT Fatigue. Scale ranges from 0 (no fatigue) to 52 (maximum fatigue).Assessment Questionnaire.
2. Local tumor control in the index quadrant of the breast (Time Frame - 2 years and 5 years after treatment start): Local tumor control in the index quadrant of the ipsilateral breast as a secondary endpoint is defined as no tumor relapse in the breast tissue quadrant of the initial tumor/ at the site of surgical intervention. Local tumor control in the index quadrant of the ipsilateral breast is used as an additional secondary endpoint to distinguish between true local recurrences in the index quadrant from second (or new) ipsilateral carcinomas in other quadrants. In the intraoperative study arm (arm B) only the former tumor bed is irradiated, while in study arm A the whole breast tissue is irradiated.
Local tumor control in the index quadrant of the breast is taken as number of days from randomization until local tumor progression, death without prior local progression, or end of follow-up. For patients alive and not diagnosed with local progression at the end of the study, the local control time will be censored at the time of the last study visit.
3. Local tumor control in the ipsilateral breast (Time Frame - 2 years and 5 years after treatment start): Local tumor control in the ipsilateral breast as a secondary endpoint is defined as no tumor relapse in the whole ipsilateral breast tissue. Local tumor control in the ipsilateral breast is taken as number of days from randomization until local tumor progression, death without prior local progression, or end of follow-up. For patients alive and not diagnosed with local progression at the end of the study, the local control time will be censored at the time of the last study visit.
Local tumor control in the index quadrant of the breast is taken as number of days from randomization until local tumor progression, death without prior local progression, or end of follow-up. For patients alive and not diagnosed with local progression at the end of the study, the local control time will be censored at the time of the last study visit.
4. Quality of life employing EORTC (European Organisation for Research and Treatment of Cancer) Quality of life questionnaires (QLQ)-C30 (Time Frame - 5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start): QoL will be analyzed with the help of the EORTC QLQ-C30. Scores are interpreted according to the guidelines of the EORTC Scoring Manual.
5. Quality of life employing BREAST-Q questionnaire (Time Frame - 5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start): The BREAST-Q questionnaire is specifically designed for patients undergoing BCS measuring quality-of-life (QOL) and satisfaction. Patients are asked to rate each item question on a four-point scale. The BREAST-Q is separated into a pre- and post-surgery version.
6. Quality of life employing BCTOS (Breast Cancer Treatment Outcome Scale) questionnaire (Time Frame - 5 weeks, 12 weeks, 6 months, 2 years, 5 years after treatment start): The Breast Cancer Treatment outcome scale (BCTOS-12) contains 12 items, which are assigned to two internally consistent subscales: 1) Functional Status, 2) Aesthetic Status. Patients are instructed to rate each item of the BCTOS-12 on a four-point scale evaluating the differences between the treated and the untreated breast (1 = no difference, 4 = large difference). The score for each subscale is the mean of the ratings over all items belonging to that subscale. A higher score reflects a poorer status (i.e. a larger difference between the treated and the untreated breast).
7. distant tumor control (Time Frame - 2 years and 5 years after treatment start): Distant tumor control is defined as no occurrence of distant metastases (lymph node metastases in the axilla, supraclavicular fossa and internal mammary chain are not classified as distant metastases, see above). Distant tumor control is defined as number of days from randomization until occurrence of distant metastases, death without prior distant progression, or end of follow-up. For patients alive and not diagnosed with distant progression at the end of the study, the distant tumor control time will be censored at the time of the last study visit.
8. Overall survival (Time Frame - 2 years and 5 years after treatment start): Overall survival time, defined as number of days from randomization until death or end of follow-up. For patients alive at the end of the study, the overall survival time will be censored at the time of the last visit or follow-up contact.
9. Disease-free survival (Time Frame - 2 years and 5 years after treatment start): Disease-free survival, defined as number of days from randomization until the first occurrence of local recurrence, regional lymph node metastases, distant metastases, tumor-related death, death without prior progression, or end of follow-up. For patients alive and not diagnosed with progression at the end of the study, the disease-free survival time will be censored at the time the patient was last known to be free of progression of tumor disease.
10. Secondary malignancies (Time Frame - 2 years and 5 years after treatment start): Frequency of secondary malignancies after 2 and 5 years will be assessed
11. Acute toxicity (Time Frame - 5 weeks after treatment start): Detailed acute potentially therapy-related toxicity will be assessed during each follow-up visit and documentation of side-effects with Common Terminology Criteria for Adverse Events and with the Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring System Schema. Documentation of toxicity will mainly focus on breast shrinkage/distortion, breast induration/ fibrosis, change of skin appearance, telangiectasia, breast oedema, numbness, fat necrosis and local pain.
12. Chronic toxicity (Time Frame - 6 months, 2 years and 5 years after treatment start): Detailed chronic potentially therapy-related toxicity will be assessed during each follow-up visit and documentation of side-effects with Common Terminology Criteria for Adverse Events and with the Radiation Therapy Oncology Group (RTOG)/ European Organization for Research and Treatment of Cancer (EORTC) Late Radiation Morbidity Scoring System Schema. Documentation of toxicity will mainly focus on breast shrinkage/distortion, breast induration/ fibrosis, change of skin appearance, telangiectasia, breast oedema, numbness, fat necrosis and local pain.
13. Cosmesis (Time Frame - 5 weeks, 12 weeks, 2 years, 5 years after treatment start): Photographic assessments before and after BCS will be taken at baseline and during follow up visits. Evaluation of breast cosmesis will be performed according to the proposed method by Vrieling et al (Schmidt ME, Chang-Claude J, Vrieling A, et al. Fatigue and quality of life in breast cancer survivors: temporal courses and long-term pattern. Journal of cancer survivorship : research and practice 2012;6:11-19.)
14. Regional tumor control (Time Frame - 2 years and 5 years after treatment start): Regional tumor control is regarded as no occurrence of regional lymph node metastases (axilla, supraclavicular fossa, internal mammary chain). Regional tumor control is defined as number of days from randomization until occurrence of regional lymph node metastases, death without prior regional tumor progression, or end of follow-up. For patients alive and not diagnosed with regional progression at the end of the study, the regional tumor control time will be censored at the time of the last study visit.
