key: cord-0985225-rk0kn53k authors: Saripalli, Anjali L.; Katz, Matthew S.; Roberge, Sherry; Hincks, Gayle; Dwyer, Kevin J.; Chakravarti, Arnab; Welsh, James S. title: Preliminary Approach to Implementing a COVID-19 Thoracic Radiation Therapy Program date: 2022-02-02 journal: Pract Radiat Oncol DOI: 10.1016/j.prro.2021.12.014 sha: 52b3f0255b288f1d8b3431e67168e047648c39b1 doc_id: 985225 cord_uid: rk0kn53k The value of low dose whole thoracic radiation therapy (LD-WTRT) for SARS-CoV-2 (COVID-19) pneumonia is unknown. Should ongoing clinical trials demonstrate that LD-WTRT proves effective for COVID-19 pneumonia recovery, widespread rapid implementation will be helpful globally. Our aim was to outline a pragmatic process for safe and efficient administration of LD-WTRT to patients with COVID-19 pneumonia that could be implemented successfully in a community hospital setting based upon participation in the PreVent clinical trial of LD-WTRT. could be implemented successfully in a community hospital setting based upon participation in the PreVent clinical trial of LD-WTRT. Radiation therapy with low doses of x-rays was historically used to treat pneumonia in the 1920s to 1940s (1) (2) (3) . Due to the advent of penicillin and increasing concerns about radiation injury, its use for non-neoplastic disease diminished sharply after World War II. The COVID-19 pandemic presents a clinical scenario where low dose radiation therapy may again provide a benefit for patients with certain types of pneumonia (4) (5) (6) . Recent and ongoing trials are investigating the efficacy and safety of low dose whole thoracic radiation therapy (LD-WTRT) to treat COVID-19 pneumonia (7) (8) (9) (10) (11) (12) (13) (14) . If LD-WTRT is shown to be efficacious, radiation oncology practices will have to adapt new procedures into their workflow to efficiently ensure the safety of both cancer center patients and staff. Here we aim to outline a pragmatic process with which to safely administer LD-WTRT to patients with COVID-19 pneumonia. The PreVent trial is a multicenter phase II clinical trial randomizing patients to best supportive care, 0.35 Gy, or 1.0 Gy of LD-WTRT. In this report, we outline the feasibility of implementing a LD-WTRT program based upon participation in the PreVent clinical trial. We worked with inpatient nursing operations and IT to access patient data. We designed an auto-populated spreadsheet (15) to screen current inpatients for identifying information, admission date, confirmed COVID-19 PCR positive test results, and oxygen use. The radiation oncologist screened patients for eligibility at 5 AM to ensure adequate time for chart review. Criteria for eligibility are shown in Table 1 . Electronic medical record (EMR) review was done for hospitalized patients deemed appropriate for LD-WTRT per discussion with the primary medical team. Information including presenting symptoms, treatment to date, whether they met protocol eligibility criteria, and diagnostic imaging was reviewed. Chest x-rays were available, but we looked for prior chest CT scans to estimate field size and potential virtual simulation for treatment. For potentially eligible patients, we contacted the hospitalist to review eligibility for consideration of LD-WTRT based upon clinical need and safety of transportation. If approved, radiation oncology consultation and screening for interest as well as eligibility for LD-WTRT was done via telehealth. The patient's nurse logged into teleconference software (16) with a hospital-linked smart tablet, donned PPE, and brought the tablet to the patient for virtual consultation. A focused history was taken to assess duration of pulmonary symptoms or fever (<9 days per protocol), ability to lie still in the supine or prone position for the time necessary for positioning and radiation treatment, and patient interest in the protocol. The historical rationale, the trial, and reason for offering LD-WTRT was reviewed in a 30-45 minute evaluation without physical examination. Ineligible patients were reassured that they were receiving standard therapy currently. For patients interested in the protocol, consent was obtained. The signature page was photographed and sent securely to clinical trials staff via mobile phone. Physical examination was then performed. To minimize risk of infection, LD-WTRT only took place at the end of the day, after the cancer center completed treatment of scheduled radiotherapy patients on the less active of two linear accelerators in the department. A member of the Infection Prevention team traveled the route from the patient unit to Radiation Oncology to ensure a safe path. Security unlocked and secured access along the transport route, through a back entrance used for patients either hospitalized or coming by ambulance. Nursing was called to coordinate transport to the Radiation Oncology department. If the patient required high-flow oxygen, respiratory therapy provided a non-rebreather mask to the patient prior to transport with medical floor nursing support if needed. The service engineer was notified to prevent unscheduled work on the linear accelerator. The patient was registered in the radiation oncology EMR (ARIA, Varian Medical Systems) and placed on a protocol-specific care path. Per protocol, CT simulation was not permitted to minimize potential departmental contamination. Diagnostic chest CT and x-ray data from the current hospitalization were used to design estimated AP/PA fields. CT scan import into the Eclipse treatment planning system (TPS) permitted confirmation of dose distribution. The carina was contoured to help with pre-treatment localization and set-up. The anatomic target was the entire thorax to include the lungs bilaterally with an estimated 1.5 to 2 cm margin in all directions. In the absence of clear lung imaging, the superior and lateral borders were identified as 2 cm beyond the outer aspect of the ribs. The inferior border was identified at the T12-L1 interspace. The only method of blocking allowed was via the primary LINAC jaws; no multileaf collimator leaves were used. In the event of superior-inferior dimension collimator limitations, we favored covering the lung bases and diaphragmatic recesses over coverage of the lung apices. Patients randomized to a protocol dose of 0.35 or 1.0 Gy had treatment prescribed to midplane along the central axis without heterogeneity corrections using 6-18 MV photons, accounting for separation at the level of the carina as identified on orthogonal KV/KV, cone beam CT or MV imaging. Isocenter was set at the carina for localization and to permit taking a separation at the central axis. Any equipment in the linear accelerator vault not being directly used by the patient was covered with a plastic sheet, placed inside a cabinet, or removed from the room. The treatment team consisted of "HOT" and "COOL" members. Two "HOT" therapists and the physician donned PPE and entered the treatment vault to set the patient up on the linac couch. The patient was positioned supine with arms in a comfortable position. Prone positioning was permitted if needed for patient safety or comfort. If a diagnostic CT was used for planning, the patient was set up in the same position as the diagnostic CT. A "COOL" therapist remained in the control room, closed the vault door, and maintained audio and visual contact with the "HOT" team members at all times. After the "HOT" team members doffed their PPE and exited the treatment vault, the physician and one therapist converted from "HOT" to "COOL" in the control area with the linac console, while the remaining "HOT" therapist donned clean PPE in preparation for post treatment re-entry. Kilovolt x-ray images were then acquired. The carina was identified and the patient was aligned to bony anatomy on the AP image. Vertical depth was identified on the lateral image and shifts were made to this point. Following isocenter placement, three MV images: central superior, inferior right lateral, and inferior left lateral were taken to verify all field borders (Figure 1 ). If these actions could not be accomplished from outside the treatment vault due to limitations of the linear accelerator, a "HOT" team member would re-enter the treatment vault to perform couch movements. Once the patient's position was confirmed by the "COOL" therapist and physician, the patient received treatment. After the patient was transported back to the hospital floor, the "HOT" therapists placed a "DO NOT ENTER" sign on the linac vault door. All three therapists and the physician then doffed their PPE following recommended procedures. Environmental Services and Housekeeping were contacted to request room decontamination. Security was notified to close the department. Using this approach, we were able to minimize COVID-19 exposure to the members of our healthcare team and other patients on treatment, and successfully deliver LD-WTRT to a patient with COVID-19 pneumonia. Zero staff and other patients contracted COVID-19 from this process. Treatment planning time to incorporate a diagnostic CT for virtual simulation, creating a DRR, and MU calculations was 20 minutes. Patient time in the department was <40 minutes, setup for verification on the couch was 15 minutes, and treatment delivery was 12 seconds (for a 1Gy dose in our patient's case). Here, we outline an approach for minimizing the exposure of patients undergoing radiation treatment for cancer to COVID-19 by delivering LD-WTRT at the end of the day. An alternative approach to minimize exposure between these different patient populations undergoing radiation treatment would be to deliver LD-WTRT during the day using a separate LINAC dedicated to these protocols. LD-WTRT for COVID-19 pneumonia is investigational and there are multiple ongoing trials to evaluate its efficacy, including the PreVent trial. Treating cancer patients on special precautions due to infection (C difficile, MRSA, etc.) is done routinely and radiation therapists already use universal precautions when needed for such situations. Using radiation to treat the infection itself, COVID-19 pneumonia specifically, however, is novel. We found implementing precautions for treatment of COVID-19 pneumonia is feasible when coordinated with the inpatient team. If studies investigating LD-WTRT for this purpose confirm its safety and efficacy, our successful process designed for a community hospital may serve as a potential model for implementation in smaller nonacademic facilities. The general process can readily be adapted to larger hospitals including academic facilities. The process described here was implemented in December 2020 which was before the FDA gave emergency use authorization for any COVID-19 vaccine. Thus, no staff had been vaccinated at the time of LD-WTRT delivery. The ability for cancer center patients, treating physicians, and staff to be vaccinated against COVID-19 has made this treatment protocol safer to implement. How radiotherapy was historically used to treat pneumonia: could it be useful today? Primary atypical pneumonia; analysis of therapeutic results in 155 cases Roentgen therapy of "virus" pneumonia Investigating low-dose thoracic radiation as a treatment for COVID-19 patients to prevent respiratory failure Low-Dose Radiation Therapy (LDRT) for COVID-19: Benefits or Risks? Lowdose radiation therapy (LDRT) for COVID-19 and its deadlier variants Low dose radiation therapy for severe COVID-19 pneumonia: a randomized double-blind study Low-dose whole-lung irradiation in severe COVID-19 pneumonia: a controlled clinical trial Lowdose whole-lung radiation for COVID-19 pneumonia: Planned day 7 interim analysis of a registered clinical trial. Cancer Whole lung irradiation as a novel treatment for COVID-19: Interim results of an ongoing phase 2 trial in India Could pulmonary low-dose radiation therapy be an alternative treatment for patients with COVID-19 pneumonia? Preliminary results of a multicenter SEOR-GICOR nonrandomized prospective trial Epub ahead of print Low-Dose Whole-Lung Irradiation for COVID-19 Pneumonia: Final Results of a Pilot Study Whole lung Irradiation as a Novel treatment for COVID-19: Interim Results of an Ongoing Phase 2 trial in India COVID-19 and low-dose radiation therapy Figure 1. To verify all field borders, three MV images were taken: central superior, inferior right lateral, and inferior left lateral Prior thoracic radiotherapy, with the exception of the following: a. Breast or post-mastectomy chest wall radiation (without regional nodal irradiation) may be included at the discretion of the site primary investigator, and b. thoracic skin radiation therapy (without regional nodal irradiation) is allowed. 3 8. Symptomatic congestive heart failure within the past 6 months including during current hospitalization 9. History of recent or current malignancy receiving any cytotoxic chemotherapy or immunotherapy within the past 6 months. 10 . History of bone marrow transplantation. 11. History of any solid organ transplant (renal, cardiac, liver, lung) requiring immunosuppressive therapy. 12. Females who are pregnant or breastfeeding. 13 . Inability to undergo radiotherapy for any other medical or cognitive issues.