Adjuvant Radiotherapy After Breast-conserving Surgery in Early Breast Cancer: Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Early-Stage Breast Carcinoma
- Sponsor
- University Hospital Schleswig-Holstein
- Enrollment
- 2324
- Locations
- 88
- Primary Endpoint
- Progression free survival
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Hypofractionation with simultaneous integrated boost has been investigated in a few trials and appears to be safe and feasible.
Investigators initiated this multicenter two-armed phase III prospective trial to analyse the non-inferiority of hypofractionation with simultaneous integrated boost in patients with early breast cancer in comparison to standard fractionation.
Detailed Description
Control Arm: Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 60.4 Gy to 66.4 Gy. or Conventionaly fractionated radiotherapy of the breast 28 × 1.8 Gy = 50.4 Gy with simultaneous integrated boost to the tumor bed, total dose 28 × 0.3 Gy or 0.45 Gy= 8.4 Gy or 12,6 Gy, total dose 58,8 Gy to 63.0 Gy. or Hypofractionated radiotherapy of the breast 16 × 2.66 Gy = 42.56 Gy followed by a tumor bed boost sequentially 5 to 8 × 2.0 Gy = 10.0 Gy to 16.0 Gy, total dose 52.56 Gy to 58.56 Gy. Experimental Arm: Hypofractionated radiotherapy of the breast 16 × 2.50 Gy with simultaneous integrated boost to the tumor bed, total dose within the boost volume 16 × 3.00 Gy.
Investigators
Juergen Dunst, Prof.
Juergen Dunst, Prof.
University Hospital Schleswig-Holstein
Eligibility Criteria
Inclusion Criteria
- •Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins independently of further risk factors (positive or high-risk negative lymph node status, estrogen- or progesterone receptor status, Her-2/neu status uPA/PAI-1 criteria) and postoperative systemic therapy (chemotherapy, endocrine, antibody or bisphosphonate therapy were permitted when indicated)
- •Indication to adjuvant radiotherapy including boost radiotherapy
- •Clearly identified primary tumor region preferably by radiopaque clips
- •Primary wound healing after breast conserving therapy without signs of infection
- •Age ≥ 18 years
- •ECOG ≤ 2 Performance Status
- •Written informed consent
- •Compliance regarding treatment appointments and toxicity
- •Linguistic and cognitive ability to understand the questionnaires
Exclusion Criteria
- •Patients operated by mastectomy
- •No indication for boost radiation (e.g. status after IORT)
- •double sided breast cancer
- •Resection margins positive for disease or insufficient identification of the boost volume
- •Indication for radiotherapy of the regional lymph nodes
- •History of prior breast or thoracic radiotherapy
- •Extended postoperative seroma at the beginning of radiotherapy
- •Previously administered radiotherapy not allowing the required dose
- •Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
- •treatment history of other cancer or participation in another clinical trial testing radiotherapy or drugs within 4 weeks of the start of treatment.
Outcomes
Primary Outcomes
Progression free survival
Time Frame: 3 to 6 years
any local or regional recurrence or distant metastasis or death
Secondary Outcomes
- Overall survival(3 to 6 years)
- Cosmetic results (NCI-CTCAE)(1 day, end of radiation (last day of radiation and closing visite), 3 months, 12 months, 24 months, 36 months, 48 months, 60 months, 72 months)
- Safety and side effects (Number of Patients with Adverse Events)(3 to 6 years)
- Time to occurence of local recurrence(3 to 6 years)
- Acute and chronic toxicity (NCI-CTCAE)(1 day, 7 days, end of radiation (last day of radiation and closing visite), 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 42 months, 48 months, 54 months, 60 months, 66 months, 72 months)