Radiation Therapy Followed by Surgery in Treating Patients With Early-Stage Breast Cancer
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.
Genetic: DNA analysis
Genetic: RNA analysis
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Procedure: fine-needle aspiration
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Radiation: accelerated partial breast irradiation
Radiation: image-guided radiation therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Image Guided Preoperative Accelerated Partial Breast Irradiation (PAPBI): Defining Radiotherapy Sensitivity|
- Gene expression profile that predicts breast cancer radiosensitivity [ Designated as safety issue: No ]
- Optimal treatment strategies [ Designated as safety issue: No ]
- Comparison of radio-induced genetic alterations on the surgical post-radiation specimen with tumor response 6 weeks after the end of radiotherapy [ Designated as safety issue: No ]
- Early changes in gene profiling [ Designated as safety issue: No ]
- Early functional-imaging modifications [ Designated as safety issue: No ]
|Study Start Date:||October 2009|
|Estimated Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
- To develop a gene expression profile that predicts the breast cancer radiosensitivity in patients with early-stage breast cancer treated with neoadjuvant image-guided preoperative accelerated partial-breast irradiation followed by surgery.
- To further design optimal treatment strategies for individual breast cancer patients treated with breast-conserving therapy (BCT).
- To assess the radio-induced genetic alterations on the surgical post-radiation specimen compared to the tumor response 6 weeks after the end of radiotherapy.
- To study the early changes in gene profiling.
- To evaluate the early functional-imaging modifications.
OUTLINE: Patients undergo image-guided preoperative accelerated partial-breast irradiation (PAPBI) 10 times over 12 days (using cone-beam CT linear accelerator for accurate tumor delineation and control of accurate radiation-dose delivery to the tumor). Beginning 6 weeks after completion of image-guided PAPBI, patients undergo surgery.
Patients undergo biopsy and fine-needle aspiration prior to and during radiotherapy and at the time of surgery. Gene expression profiling from RNA and DNA isolated from these samples are used to identify breast cancer radiosensitivity. biopsies and fine needle aspiration taken of the tumor before, during radiotherapy and at time of operation. The mRNA gene expression profiles, the miRNA expression profiles and the DNA copy number changes are correlated with response to radiotherapy (defined as pathologic response at the time of the lumpectomy [i.e. 6 weeks after the completion of the PAPBI]).
Fresh-frozen tumor tissue, blood, and urine samples are also collected to assess the radio-induced genetic alterations; to study the early changes in gene profiling; and to evaluate the early functional-imaging modifications.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01024582
|Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital||Recruiting|
|Amsterdam, Netherlands, 1066 BE|
|Contact: Contact Person 31-20-512-1714 firstname.lastname@example.org|
|Principal Investigator:||Paula Elkhuizen, MD||The Netherlands Cancer Institute|