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| ID | Type | Description | Link |
|---|---|---|---|
| NL24996.031.08 | Registry Identifier | CCMO | |
| EU-20989 |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| accelerated partial breast irradiation | Experimental | pre-operative radiation of the in situ tumor in the breast |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy | Procedure | before treatment a biopsy will be taken to confirm breast cancer type |
|
| Measure | Description | Time Frame |
|---|---|---|
| local recurrence | Local recurrences should not exceed 4% at 5 years of follow-up | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| breast fibrosis | decrease from 27% as found in the boost arm of the EORTC boost-no boost trial to 15% | 5 years |
| cosmetic outcome | is anticipated that the overall score for cosmetic outcome will be superior compared to conventional whole breast postoperative radiotherapy plus boost. |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Paula Elkhuizen, MD | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Amsterdam | 1066 BE | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25701298 | Derived | van der Leij F, Bosma SC, van de Vijver MJ, Wesseling J, Vreeswijk S, Rivera S, Bourgier C, Garbay JR, Foukakis T, Lekberg T, van den Bongard DH, van Vliet-Vroegindeweij C, Bartelink H, Rutgers EJ, Elkhuizen PH. First results of the preoperative accelerated partial breast irradiation (PAPBI) trial. Radiother Oncol. 2015 Mar;114(3):322-7. doi: 10.1016/j.radonc.2015.02.002. Epub 2015 Feb 17. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| D044963 | Biopsy, Fine-Needle |
| D061089 | Radiotherapy, Image-Guided |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| fine-needle aspiration | Procedure | at FNA tumor material will be collected and fresh frozen for micro-analyses; parafin embedded tissue will bestored for tissue-array analysis |
|
| accelerated partial breast irradiation | Radiation |
|
| image-guided radiation therapy | Radiation |
|
| 5 years |
| Pathological response | 6 weeks after finishing iradiation treatment |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D001707 | Biopsy, Needle |
| D011677 | Punctures |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |