Early-Stage Breast Carcinoma
Conditions
Keywords
Breast cancer, Hypofractionation with SIB, Non-inferiority, adjuvant radiotherapy with simultaneous integrated boost
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.
Interventions
RADIATIONStandard Radiation
Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially
RADIATIONHypofractionation with SIB
Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
Sponsors
University of Luebeck
University Hospital Schleswig-Holstein
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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. * Patients with serious, uncontrolled, physical or cerebrovascular disorders(e.g. myocardial infarction within the last 12 months) or neurologiy or psychiatric disorders thought to adversly affect treatment compliance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 3 to 6 years | any local or regional recurrence or distant metastasis or death |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to occurence of local recurrence | 3 to 6 years | ipsilateral in-breast recurrence |
| Overall survival | 3 to 6 years | death |
| Safety and side effects (Number of Patients with Adverse Events) | 3 to 6 years | Number of Patients with Adverse Events |
| 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 | All dimensions of NCI-CTCAE |
| 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 | NCI-CTCAE |
Countries
Germany
Outcome results
None listed