Purpose To analyze the toxicity and patterns of failure of proton therapy given in ablative doses for medically inoperable early-stage non-small cell lung cancer (NSCLC). Methods and Materials Eighteen patients with medically inoperable T1N0M0 (central location) or T2-3N0M0 (any location) NSCLC were treated with proton therapy at 87.5 Gy (relative biological effectiveness, RBE) at 2.5 Gy/fraction in this phase I/II study. All patients underwent treatment simulation with 4-dimensional (4D) computed tomography (CT); internal gross tumor volumes (iGTVs) were delineated on maximal intensity projection (MIP) images and modified by visual verification of the target volume in 10 breathing phases. The iGTV with MIP density was used to design compensators and apertures to account for tumor motion. Therapy consisted of passively scattered protons. All patients underwent repeat 4D CT simulations during treatment to assess the need for adaptive replanning. Results At a median follow-up time of 16.3 months (range, 4.8–36.3 months), no patient had experienced grade 4 or 5 toxicity. The most common adverse effect was dermatitis (grade 2, 67%; grade 3, 17%), followed by grade 2 fatigue (44%), grade 2 pneumonitis (11%), grade 2 esophagitis (6%), and grade 2 chest wall pain (6%). Rates of local control were 88.9%, regional lymph node failure 11.1%, and distant metastasis 27.8%. Twelve patients (67%) were still alive at the last follow-up; five had died of metastatic disease and one of preexisting cardiac disease. Conclusions Proton therapy to ablative doses is well tolerated and produces promising local control rates for medically inoperable early-stage NSCLC.

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Introduction Clinical trial enrollment has declined globally due to the COVID-19 pandemic. This underscores the importance of structured methods to continue critical medical research safely and efficiently. Methods We report the impact of a phased trial reopening strategy, remote research staffing, and telemedicine on cancer trial enrollment at one of the largest Radiation Oncology academic cancer centers. In Phase 1, trials investigating definitive therapeutic benefit were opened, followed by trials not increasing patient exposure or pulmonary toxicity risk in Phase 2. During Phase 2.5, multicenter trials reopened and limited research staff were allowed on-site. Results Despite initial enrollment declines during the early pandemic, the percentage of new patients enrolling in clinical trials from March to August 2020 was 8.8%, and represented an 10.5% relative increase from 2019. Monthly accrual enrollment from March to August 2019 ranged from 42-71 compared to enrollment during COVID-19 from 23-73 patients (p<0.001). Conclusions Through a phased approach to trial reopening and adaptive techniques, the Division of Radiation Oncology maintained cancer trial accrual during the COVID-19 pandemic. The experience may help centers maintain accrual, preserve clinical trial integrity, and minimize risk to patients and staff.

Conclusion and relevance Considering the positive results obtained so far, the study of HIPEC with CRS in peritoneal carcinoma continues, to evaluate its effectiveness. The role of the pharmacist was important in participating in the multidisciplinary team in terms of eligibility of patients for treatment, to prepare oncological therapies and in processing the evaluation data.

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