A phase 2 study of stereotactic body radiation therapy for squamous cell carcinoma of the head and neck (SHINE): a single arm clinical trial protocol.

BACKGROUND: Cancers of the head and neck region are often characterized by locally advanced, non-metastatic disease. Standard treatments for advanced cervico-facial cancers of the skin or primary head and neck squamous cell carcinoma (HNSCC) include combinations of surgery, radiation and chemotherapy, which are associated with high rates of acute toxicity and complications. Stereotactic body radiotherapy (SBRT) has been shown to be a promising modality of treatment for this patient population in retrospective studies; to our knowledge, there are no prospective clinical studies evaluating the safety and efficacy of SBRT in these patients. METHODS: This phase 2, single institution, single arm study aims to evaluate response rates to SBRT in older age patients with locally advanced HNSCC for whom primary surgery is not recommended or performed. The intervention is SBRT 45 Gy in 5 fractions given every 3-4 days. Toxicity, quality of life and patient outcomes will be recorded regularly up to 24 months after completion of SBRT. DISCUSSION: For this patient population, SBRT may offer a shorter and more effective treatment than the current standard of care palliative regimens. If the study demonstrates that SBRT is safe and effective, then this may lead to randomized studies comparing conventional radiotherapy to SBRT for selected head and neck cancer patients. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04435938 .  Date registered: June 17, 2020.

An Evaluation of Two Approaches to Skin Bolus Design for Patients Receiving Radiotherapy for Head and Neck Cancers.

PURPOSE: This radiation treatment planning study compares two approaches to designing a bolus for patients with head and neck cancer. Our current approach, based on clinical examination, is compared with an alternative approach, based on the patient's computed tomographic image data set, to investigate potential improvements in delivering the prescribed dose to the superficial regions of the clinical target volume (CTV) while limiting the dose to normal skin. METHODS: Twelve consecutive head and neck radiotherapy plans requiring a bolus were selected. A clinically placed bolus was designed by a radiation oncologist through physical examination of the patient. A virtual bolus was designed using an algorithm that configured it to overlay only the superficial CTV delineated on the patient's CT data set. These two approaches were compared on the basis of dose-volume histograms of normal skin and the superficial CTV, as well as the total bolus area. RESULTS: Of 12 patients, the virtual bolus plan resulted in a decrease in the bolus area of at least 4 cm2 for nine patients, an increase in the bolus area of at least 30 cm2 for three patients, and an improvement in the minimum dose to the superficial CTV in six patients. Of these six patients, half had a reduction in the bolus area with a corresponding modest 2% improvement in the minimum dose to the superficial CTV, whereas the other half had an increase in the bolus area with a corresponding dramatic 10%-57% improvement in the minimum dose to the superficial CTV. CONCLUSIONS: Basing bolus design on computed tomography image data rather than on clinical examination reduced the area of normal skin under the bolus in 9 patients (75%) and improved dose coverage of the superficial CTV in 3 patients (25%). All plans benefited from the virtual bolus approach because it has been shown to be more appropriate for balancing skin sparing with target coverage.

An opposed matched field IMRT technique for prostate cancer patients with bilateral prosthetic hips.

Intensity-modulated radiation therapy (IMRT) has gained wide-spread use for treating patients with prostate cancer, yet developing a plan for patients with bi-lateral metal hip prostheses implants may be challenging. The high atomic number of the metallic hips not only gives rise to streak artifacts that obscure anatomy but also attenuates laterally directed fields by a significant amount that cannot be reliably ascertained from the CT dataset. A common approach to planning directs five IMRT fields such that incidence through the metal hips is avoided. While this technique generally gives adequate PTV coverage, it may escalate the rectal dose if beams, which would otherwise be incident from a lateral direction, are angled toward a posterior direction in order to avoid the prosthesis. In this work, we propose and investigate a new technique which alleviates this problem by introducing asymmetric opposed fields that are edge-matched along a plane that is tangent to the metal prostheses. With this approach, a posterior oblique field is oriented closer to the lateral direction but does not irradiate the ipsilateral prosthesis. The portion of the target eclipsed by the prosthesis is irradiated by the opposed matched anterior oblique field which, again, avoids the corresponding ipsilateral prosthesis. While the proposed technique may improve rectal sparing and PTV coverage, the dose along the match plane is sensitive to intrafraction motion. In the worse case of intrafraction motion perpendicular to the plane occurring in the time interval between the deliveries of successive fields of the opposed matched pair, the induced error is typically about 5 cGy per mm of target motion for a 200 cGy fraction. To reduce the induced error, several approaches to broadening the penumbra at the match plane were investigated and compared to conventional IMRT plans for three patients. Phantom measurements were performed to evaluate the effectiveness of these approaches. Match-plane shifts of 4 mm in a single step, in two 2 mm steps, and in four 1 mm steps, were effective in reducing the worse case induced error to 2.8 cGy per mm. Imposing match-plane shifts precludes the use of intensity modulation for the opposed matched field pairs. Therefore, we favor an approach whereby the opposed matched fields overlap by 4 mm. Since both fields contribute fluence to the overlap region, the worse case induced error was observed to be typically within 2.9 cGy per mm. In conclusion, the use of this technique should be considered for patients with bilateral metal hip implants who do not meet dose-volume criteria by conventional IMRT techniques.

An empirical model of electronic portal imager response implemented within a commercial treatment planning system for verification of intensity-modulated radiation therapy fields.

Quality assurance (QA) of an intensity-modulated radiation therapy (IMRT) plan is more complex than that of a conventional plan. To improve the efficiency of QA, electronic portal imaging devices (EPIDs) can be used. The major objective of the present work was to use a commercial treatment planning system to model EPID response for the purpose of pre-treatment IMRT dose verification. Images were acquired with an amorphous silicon flat panel portal imager (aS500: Varian Medical Systems, Palo Alto, CA) directly irradiated with a 6-MV photon beam from a Clinac 21EX linear accelerator (Varian Medical Systems). Portal images were acquired for a variety of rectangular fields, from which profiles and relative output factors were extracted. A dedicated machine model was created using the physics tools of the Pinnacle3 (Philips Medical Systems, Madison, WI) treatment planning system to model the data. Starting with the known photon spectrum and assuming an effective depth of 7 cm, machine model parameters were adjusted to best fit measured profile and output factors. The machine parameters of a second model, which assumed a 0.8 MeV monoenergetic photon spectrum and an effective depth in water of 3 cm, were also optimized. The second EPID machine model was used to calculate planar dose maps of simple geometric IMRT fields as well as a 9-field IMRT plan developed for clinical trials credentialing purposes. The choice of energy and depth for an EPID machine model influenced the best achievable fit of the optimized machine model to the measured data. When both energy and depth were reduced by a significant amount, a better overall fit was achieved. In either case, the secondary source size and strength could be adjusted to give reasonable agreement with measured data. The gamma evaluation method was used to compare planar dose maps calculated using the second EPID machine model with the EPID images of small IMRT fields. In each case, more than 95% of points fell within 3% of the maximum dose or 3 mm distance to agreement. These results are slightly poorer than those obtained using an ion chamber array, which confirms agreement to within 2% of the maximum dose or 2 mm distance to agreement for all points within these fields.

Analysis of mechanical sources of patient alignment errors in radiation therapy.

Certain radiation treatments, such as conformal and intensity modulated treatments, involve isocentric treatment fields delivered using multiple angles or continuous angulation of the gantry, collimator and table. At our institution, treatments involving three angles (gantry, collimator, and table) can, if uncorrected, exhibit misalignments of 2 mm or more on premarked field centers and borders on the patient surface during the initial setup on a linear accelerator (linac), even though the linac operates within allowable mechanical tolerances. This paper is an analysis of three principal mechanical sources of patient alignment errors observed on linacs: (i) errors in table and gantry angle, (ii) displacement of gantry rotational axis during gantry rotation, and (iii) displacement between collimator and table rotational axes. On patient surfaces, these small, systematic mechanical errors can each be expected to produce misalignments of up to 1.5 mm, increasing to over 2 mm with nearly horizontal fields delivered at nonzero table angles onto highly oblique patient surfaces. For the underlying target volumes, the mechanical errors can, in combination, be expected to produce target volume misalignments of up to 1 mm on newly installed linacs and 3 mm on older linacs. Thus, 1 mm appears to be a mechanical limit on the positional precision of radiation treatments.