Hypofractionation With Simultaneous Integrated Boost vs. Standard Fractionation in Early Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Early-Stage Breast Carcinoma

• Registration Number: NCT02474641
• Lead Sponsor: University Hospital Schleswig-Holstein

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.

Study Timeline

• Study First Submitted: 2015-06-04
• Study Start: 2015-06-16
• Study First Submitted QC: 2015-06-17
• Study First Posted: 2015-06-18
• Primary Completion: 2019-01-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-19
• Last Update Posted: 2024-03-21
• Study Completion: 2028-03-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 2324

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Progression free survival	3 to 6 years	any local or regional recurrence or distant metastasis or death

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (88)

Gesundheitszentrum St.Marien Gmbh und Klinik für Strahlentherapie; 🇩🇪 Amberg, Germany

Medizinisches Versorgungszentrum Aue; 🇩🇪 Aue, Germany

Helios Kliniken Bad Saarow Klinik für Radioonkologie; 🇩🇪 Bad Saarow, Germany

HELIOS Klinikum Bad Saarow; 🇩🇪 Bad Saarow, Germany

Strahlentherapie Klinikum Bayreuth; 🇩🇪 Bayreuth, Germany

MVZ Chariete Vivantes Gmbh Strahlentherapie; 🇩🇪 Berlin ( Mitte), Germany

Medizinisches Versorgungs Zentrum Diagnostisch Therapeutisches Zentrum am Frankfurter Tor; 🇩🇪 Berlin, Germany

Strahlentherapie in Moabit /Praxis für Strahlentherapie; 🇩🇪 Berlin, Germany

Praxis für Radioonkologie und Strahlentherapie Berlin Südwest; 🇩🇪 Berlin, Germany

Ambulantes Gesundheitszentrum der Dr. med Maria Sternemann Charte -Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

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