Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT)

Official title

Accelerated Partial Breast Irradiation (APBI) Using Stereotactic Body Radiation Therapy (SBRT): a Multicenter, Observational Clinical Trial

Overview

This is a multi-institutional, prospective, observational registry investigating the safety and efficacy of Accelerated Partial Breast Irradiation (APBI) using a Stereotactic Body Radiation Therapy (SBRT) delivery technique that incorporates real-time image guidance, noncoplanar fields, and respiratory tracking. The study will accrue 200 patients who will be treated to a dose of 30 Gy over the course of 5 fractions. These subjects will then have a follow up time of 5 years

Detailed description

RADIATION TREATMENT GUIDELINES and DOSIMETRY Fiducial Placement Prior to enrollment, patients will undergo breast conservation surgery preferably with fiducial markers implanted at the time of surgery or under ultrasonic guidance25

Patients treated with gantry-based SBRT preferably will have fiducials placed at the time of surgery.

For patients being treated with CyberKnife SBRT, four gold markers will be placed intraoperatively or ultrasonically to define the superior, inferior, medial, and lateral boundaries of the lumpectomy cavity in accordance with the manufacturer's (Accuray) documentation. At least three fiducials will be required for target tracking purposes to allow for rotational changes.

Simulation Linear Accelerator SBRT For treatments on a gantry-based linear accelerator, patients will be positioned supine with the arms elevated. CT scans will be obtained with 1.25 mm thickness and will be acquired with free breathing as well as additional scans as needed for motion control or gating. 4DCT, MRI and PET imaging may be used to assist in determining motion estimation.

CyberKnife SBRT For treatment on a robotic system, a contrast enhanced CT simulation is to be performed with 1 mm slices with the patient's arms at her sides in the supine position. The scan is to be performed with end-inspiratory breath hold from the thyroid to below the lungs. Breast immobilization devices including a vacuum mattress and a bra system will be allowed however bolus should not be used. Fiducial tracking (Synchrony) is to be used for motion tracking.

DOSIMETRY Target and Organs at Risk (OAR) contours

The following structures are to be contoured in all patients:

Tumor cavity (GTV) as defined on CT including all fiducials implanted on CT images Clinical Target Volume (CTV) defined as the tumor cavity expanded by a uniform 15 mm margin. The CTV will not extend beyond the skin, breast or chestwall Planning Tumor Volume (PTV) for SBRT will be defined as the CTV plus 3 - 5 mm as needed at the treating physician's discretion. PTV will be limited to GTV plus 20 mm margin Skin is defined as \<5 mm inside the external contour Chest wall includes the ribs and intercoastal musculature but does not include the pectoralis Heart contour begins below the level of where the pulmonary trunk branches into the left and right pulmonary arteries Lungs are to be contoured separately Spinal canal Breasts are to be contoured separately Dose Prescription The total prescribed dose to the PTV is 30 Gy delivered in 5 equal fractions of 6 Gy per day delivered on alternating days over 5 -10 total days. The prescribed dose must cover at least 95% of the PTV.

Interventions

• Radiation stereotactic body radiation therapy
  Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less

Primary outcome measures

• Breast Cosmesis as measured by NRG-Radiation Therapy Oncology Group (RTOG) global cosmetic score (GCS) and the Harvard Cosmesis Scale (HCS) [Time frame: 2-3 years]
• Acute breast toxicity as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [Time frame: 1-6 weeks]
• Other late toxicities as measured by Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [Time frame: 3-60 months]

Eligibility criteria

Inclusion criteria

• Women 50 years or older
• Low to intermediate grade DCIS or invasive ductal carcinoma
• Tumor size < 2 cm invasive ductal carcinoma and < 2.5 cm DCIS
• Well defined lumpectomy cavity on CT
• Clear surgical ink margins > 2mm for invasive cancer and > 3 mm for DCIS
• Node negative
• Unifocal lesion
• ER and/or PR positive
• HER-2 negative
• BRCA negative
• Lumpectomy cavity must be < 30% of whole breast volume

Exclusion criteria

• Lobular histology
• Angiolymphatic invasion
• Multiple foci of disease
• Lymphovascular invasion
• Active lupus or sarcoid
• Distant metastases
• Non-epithelial malignancies
• Synchronous contralateral breast cancer
• Grade 2 or higher oncoplastic surgery
• Ipsilateral pacemaker
• Ipsilateral breast implant
• Neoadjuvant chemotherapy
• Prior ipsilateral breast cancer or thoracic radiation
• Poor breast integrity
• Paget's Disease of the nipple
• Pregnant patients
• Severe cardiac, pulmonary, or liver diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Case-only

Study locations

United States · 2 centers

• CyberKnife Center of South Florida in Stuart — Stuart
• CyberKnife Centers of Tampa Bay — Tampa

Publications

• National Comprehensive Cancer Network. Invasive Breast Cancer (Version 1.2021) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
• 2Bonfantini F, De Martin E, Giandini T, Fumagalli ML, Cavallo A, Pinzi V, et al. A Dosimetric Comparison between Three Different External Photon Beam Techniques for Accelerated Partial Breast Irradiation. Clin Oncol. 2018; 3:1501.
• Hepel JT, Tokita M, MacAusland SG, Evans SB, Hiatt JR, Price LL, DiPetrillo T, Wazer DE. Toxicity of three-dimensional conformal radiotherapy for accelerated partial breast irradiation. Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1290-6. doi: 10.1016/j.ijrobp.2009.01.009. Epub 2009 Apr 22. PMID 19395195
• Wolmark N, Curran WJ, Vicini F, White J, Costantino JP, Arthur D, Kuske R, Rabinovitch R, Julian TB, Parda DS. Response to "Unacceptable cosmesis in a protocol investigating intensity-modulated radiotherapy with active breathing control for accelerated partial-breast irradiation" (Int J Radiat Oncol Biol Phys 2010;76:71-78) and "Toxicity of three-dimensional conformal radiotherapy for accelerated PMID 20394863
• Whelan TJ, Julian JA, Berrang TS, Kim DH, Germain I, Nichol AM, Akra M, Lavertu S, Germain F, Fyles A, Trotter T, Perera FE, Balkwill S, Chafe S, McGowan T, Muanza T, Beckham WA, Chua BH, Gu CS, Levine MN, Olivotto IA; RAPID Trial Investigators. External beam accelerated partial breast irradiation versus whole breast irradiation after breast conserving surgery in women with ductal carcinoma in sit PMID 31813635
• Vicini FA, Cecchini RS, White JR, Arthur DW, Julian TB, Rabinovitch RA, Kuske RR, Ganz PA, Parda DS, Scheier MF, Winter KA, Paik S, Kuerer HM, Vallow LA, Pierce LJ, Mamounas EP, McCormick B, Costantino JP, Bear HD, Germain I, Gustafson G, Grossheim L, Petersen IA, Hudes RS, Curran WJ Jr, Bryant JL, Wolmark N. Long-term primary results of accelerated partial breast irradiation after breast-conservi PMID 31813636
• 7White J. Cosmetic Outcomes from Post Lumpectomy Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) on the NRG Oncology/NSABP B39-RTOG 0413 Phase III Clinical Trial. ASTRO Annual Meeting. November 10, 2019.
• Coles CE, Griffin CL, Kirby AM, Titley J, Agrawal RK, Alhasso A, Bhattacharya IS, Brunt AM, Ciurlionis L, Chan C, Donovan EM, Emson MA, Harnett AN, Haviland JS, Hopwood P, Jefford ML, Kaggwa R, Sawyer EJ, Syndikus I, Tsang YM, Wheatley DA, Wilcox M, Yarnold JR, Bliss JM; IMPORT Trialists. Partial-breast radiotherapy after breast conservation surgery for patients with early breast cancer (UK IMPORT PMID 28779963

Identifiers

NCT: NCT04985032 · RPCR-breast 01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗