40 research outputs found

    Preservation of swallowing in resected oral cavity squamous cell carcinoma: examining radiation volume effects (PRESERVE): study protocol for a randomized phase II trial

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    Background: Patients with resected oral cavity squamous cell carcinoma (OCSCC) are often treated with adjuvant radiation (RT) ± concomitant chemotherapy based on pathological findings. Standard RT volumes include all surgically dissected areas, including the tumour bed and dissected neck. RT has significant acute and long-term toxicities including odynophagia, dysphagia, dermatitis and fibrosis. The goal of this study is to assess the rate of regional failure with omission of radiation to the surgically dissected pathologically node negative (pN0) hemi-neck(s) compared to historical control, and to compare oncologic outcomes, toxicity, and quality of life (QoL) profiles between standard RT volumes and omission of RT to the pN0 neck. Methods: This is a multicentre phase II study randomizing 90 patients with T1-4 N0-2 OCSCC with at least one pN0 hemi-neck in a 1:2 ratio between standard RT volumes and omission of RT to the pN0 hemi-neck(s). Patients will be stratified based on overall nodal status (nodal involvement vs. no nodal involvement) and use of concurrent chemotherapy. The primary endpoint is regional failure in the pN0 hemi-neck(s); we hypothesize that a 2-year regional recurrence of 20% or less will be achieved. Secondary endpoints include overall and progression-free survival, local recurrence, rate of salvage therapy, toxicity and QoL. Discussion: This study will provide an assessment of omission of RT to the dissected pN0 hemi-neck(s) on oncologic outcomes, QoL and toxicity. Results will inform the design of future definitive phase III trials. Trial registration: Clinicaltrials.gov identifier: NCT03997643 . Date of registration: June 25, 2019, Current version: 2.0 on July 11 2020. Keywords: De-escalation; Head and neck cancer; Oral cavity; Quality of life; Radiotherapy; Randomized controlled trial; Recurrence; Survival

    Interobserver Reliability in Describing Radiographic Lung Changes After Stereotactic Body Radiation Therapy

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    Purpose Radiographic lung changes after stereotactic body radiation therapy (SBRT) vary widely between patients. Standardized descriptions of acute (≤6 months after treatment) and late (\u3e6 months after treatment) benign lung changes have been proposed but the reliable application of these classification systems has not been demonstrated. Herein, we examine the interobserver reliability of classifying acute and late lung changes after SBRT. Methods and materials A total of 280 follow-up computed tomography scans at 3, 6, and 12 months post-treatment were analyzed in 100 patients undergoing thoracic SBRT. Standardized descriptions of acute lung changes (3- and 6-month scans) include diffuse consolidation, patchy consolidation and ground glass opacity (GGO), diffuse GGO, patchy GGO, and no change. Late lung change classifications (12-month scans) include modified conventional pattern, mass-like pattern, scar-like pattern, and no change. Five physicians scored the images independently in a blinded fashion. Fleiss\u27 kappa scores quantified the interobserver agreement. Results The Kappa scores were 0.30 at 3 months, 0.20 at 6 months, and 0.25 at 12 months. The proportion of patients in each category at 3 and 6 months was as follows: Diffuse consolidation 11% and 21%; patchy consolidation and GGO 15% and 28%; diffuse GGO 10% and 11%; patchy GGO 15% and 15%; and no change 49% and 25%, respectively. The percentage of patients in each category at 12 months was as follows: Modified conventional 46%; mass-like 16%; scar-like 26%; and no change 12%. Uniform scoring between the observers occurred in 26, 8, and 14 cases at 3, 6, and 12 months, respectively. Conclusions Interobserver reliability scores indicate a fair agreement to classify radiographic lung changes after SBRT. Qualitative descriptions are insufficient to categorize these findings because most patient scans do not fit clearly into a single classification. Categorization at 6 months may be the most difficult because late and acute lung changes can arise at that time

    Local Radiotherapy Intensification for Locally Advanced Non–small-cell Lung Cancer – A Call to Arms

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    Chemoradiotherapy, the standard of care for locally advanced non–small-cell lung cancer (NSCLC), often fails to eradicate all known disease. Despite advances in chemotherapeutic regimens, locally advanced NSCLC remains a difficult disease to treat, and locoregional failure remains common. Improved radiographic detection can identify patients at significant risk of locoregional failure after definitive treatment, and newer methods of escalating locoregional treatment may allow for improvements in locoregional control with acceptable toxicity. This review addresses critical issues in escalating local therapy, focusing on using serial positron emission tomography-computed tomography to select high-risk patients and employing stereotactic radiotherapy to intensify treatment. We further propose a clinical trial concept that incorporates the review's findings
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