NCT01024582

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

Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 139 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 60 Years – 120 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	biopsy	before treatment a biopsy will be taken to confirm breast cancer type
PROCEDURE	fine-needle aspiration	at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis
RADIATION	accelerated partial breast irradiation
RADIATION	image-guided radiation therapy

Timeline

• Start date: 2009-10-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2009-12-03
• Last updated: 2017-09-27

Locations

1 site across 1 country: Netherlands