Postoperative Radiation of Patients With Breast Cancer in... | NCT05452083

Studies
Postoperative Radiation of Patients With Breast Cancer in Extreme Hypofractionation.

NCT05452083

Sponsor

University of Erlangen-Nürnberg Medical School

Status

Not yet recruiting

Last Update Posted

Jul 11, 2022Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2022Estimated

Primary Completion Date

Jul 30, 2025Estimated

Completion Date

Jul 30, 2035Estimated

First Submitted Date

Apr 22, 2022

First Submission Date that Met QC Criteria

Jul 6, 2022

First Posted Date

Jul 11, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 6, 2022

Last Update Posted Date

Jul 11, 2022Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Claudia Schweizer, Dr. med. Claudia Schweizer, University of Erlangen-Nürnberg Medical SchoolPrincipal Investigator

Lead Sponsor

University of Erlangen-Nürnberg Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

The focus of this phase 2-trial is set on feasibility as well as early and late toxicity rates. One possible disadvantage of extreme hypofractionation could be an increased rate of fibrosis within the irradiated region. Therefore, a closer look will be taken with this prospective trial.

In addition, we are planning an accompanying translational research program since hypofractionated schedules are suggested to be more immunogenic in breast cancer.

Secondary objectives therefore are: cosmetic outcome, local tumor control, quality of life, dynamic immune status, importance of tumor infiltrating immune cells, overall survival, disease-free survival, feasibility of breath-hold radiation technique.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Cosmetic results according to the Harvard-scale	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)	05/2022 - 04/2035
In-breast recurrence rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with breast cancer after complete resection and the indication for postoperative radiotherapy.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided