Clinical trial · Observational

Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

Postoperative External Beam Whole Breast or Chest Wall Irradiation of Patients With Breast Cancer in Extreme Hypofractionation.

NCT05452083CI-TRIAL-00059589not yet recruitingClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

Evaluation of treatment toxicity of extreme hypofractionation of the whole breast in five fractions of 5.2 Gy in five consecutive workdays.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (0)

Data not yet available

No intervention recorded.

Design

Arms and outcomes

Arms (0)

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Primary outcomes (1)

measure
Incidence and grade of Treatment related adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE 5.0)
timeFrame
08/2022 - 07/2035
description
Evaluation during treatment and at each follow-up visit up to 10 years

Secondary outcomes (6)

measure
Cosmetic results according to the Harvard-scale
timeFrame
05/2022 - 04/2035
description
Clinical evaluation of the irradiated breast at each follow-up up to 10 years according to the Harvard-scale (patient's and physician's view)
measure
In-breast recurrence rate
timeFrame
05/2022 - 04/2035
description
Evaluation at each follow-up up to 10 years via regular examinations including mammography/ ultrasound

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* Histologically confirmed invasive breast cancer or ductal carcinoma in situ (DCIS)
* pT-category pT0-3
* complete resection (R0)
* Absence of distant metastasis (M0)
* Absence of contralateral breast cancer/ DCIS
* Karnofsky Performance Score ≥ 60%
* Age ≥ 18 years at time of study entry
* Written informed consent

Exclusion Criteria:

* All patients not fulfilling inclusion criteria
* Morbus Paget or pathological skin infiltration
* Earlier or synchronous breast cancer
* Pregnant or breast-feeding women
* Increased radiosensitivity or any genetic disposition for increased radiosensitivity, e.g. ataxia telangiectatica
* Judgement by the investigator that the patient is unlikely to comply with study procedures and requirements

References

Publications (0)

Data not yet available

No reference posted for this study.