Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01024582
• Lead Sponsor: The Netherlands Cancer Institute

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving CT-guided accelerated radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This clinical trial is studying giving radiation therapy followed by surgery to see how well it works in treating patients with early-stage breast cancer.

Detailed Description

OBJECTIVES:

* is to investigate the impact of a short fractionated schedule given preoperatively on local control, cosmesis and breast fibrosis.

* To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT) on the basis of biological parameters, including the expression profile of the primary tumor, for both m-RNA as for micro-RNA, with first, a focus on radiotherapy responsiveness and second, on local recurrence rate, distant metastases and survival.

* proteomics will be studied in fine-needle aspiration samples. A classifier can be build (genomic or proteomic or any kind of molecular signature) to identify responders and non-responders

* quality of life

OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (10 x 4 Gy) and later in the study 5 times 6 Gy. Six weeks after completion of image-guided PAPBI, patients undergo surgery.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2017-03
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
local recurrence	5 years	Local recurrences should not exceed 4% at 5 years of follow-up

Secondary Outcome Measures

Name	Time	Method
Pathological response	6 weeks after finishing iradiation treatment
cosmetic outcome	5 years	is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost.
breast fibrosis	5 years	decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15%

Trial Locations

Locations (1)

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands