https://doi.org/10.1177/0300891620933672 Tumori Journal 2020, Vol. 106(4) 271–272 © Fondazione IRCCS Istituto Nazionale dei Tumori 2020 Article reuse guidelines: sagepub.com/journals-permissions DOI: 10.1177/0300891620933672 journals.sagepub.com/home/tmj TJ Tumori Journal System-wide changes made to reduce coronavirus disease 2019 (COVID-19) infection spread could have a negative impact on oncologic therapeutic procedures and approaches. There is the need to continue lifesaving treatments, but COVID-19 hospital reorganization may prevent the hospi- tal from using its full armamentarium in the cancer battle. Thus different therapeutic modalities have been recom- mended. 1–5 During the pandemic, despite regulatory agen- cies’ recommendations, several considerations and doubts remain for oncologic clinical trials. 6 Considering patients who had been enrolled before the pandemic, and who plan to take study medication, the situ- ation becomes complicated. These patients should undergo monitoring visits, blood sampling, questionnaire, physical examination, and drug and radiation administration. To avoid deviations from the protocol and trial discontinua- tion, the follow-up should be performed regularly, in con- cordance with safety guidelines: • Telephone triage for symptomatology evaluation and assessment of COVID-19 exposure, and if pos- sible, for case report form data collection • Drug delivery to patients’ homes when in quarantine • Access to the hospital with the use of personal pro- tective equipment, including at COVID-19 hospi- tals, ensuring a non–COVID-19 route Our urology department is involved in PROTEUS (A Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy). One enrolled patient was in quarantine due to prior contact with a patient with COVID- 19. Therefore, precautionary measures were adopted for the management of visits and the drug under study, with devia- tions from the protocol. In addition, the company provided guidance with regard to urgent safety measures that can be adopted immediately in the current pandemic situation based on guidance from regulatory agencies and health authorities, including drug shipment to patients, remote visits for patients under quarantine, use of local laboratory assessments, and others. If follow-up clinical visits could be managed easily with such measures, several questions Patients with cancer in the COVID-19 era: the clinical trial issue Marcello Scarcia 1 , Giuseppe Mario Ludovico 1 , Angela Fortunato 1 and Alba Fiorentino 2 Abstract Coronavirus disease 2019 (COVID-19) hospital reorganization may result in reduced ability for the hospital to fully use its armamentarium for battling cancer. Thus different therapeutic modalities have been recommended. During the pandemic, despite regulatory agencies’ recommendations, several considerations and doubts remain for oncologic clinical trials. Considering patients who had been enrolled before the pandemic, and who plan to take the study medication, the situation becomes complicated. These patients should undergo monitoring visits, blood sampling, questionnaire, physical examination, and drug and radiation administration. To avoid deviations from the protocol and trial discontinuation, follow-up should be performed regularly, in concordance with safety guidelines. Here we report several considerations. Keywords COVID-19, clinical trials, oncology Date received: 11 May 2020; revised: 19 May 2020; accepted: 20 May 2020 1 Urology Department, General Regional Hospital F. Miulli, Acquaviva delle fonti (BA), Italy 2 Radiation Oncology Department, General Regional Hospital F. Miulli, Acquaviva delle fonti (BA), Italy Corresponding author: Alba Fiorentino, MD, Radiation Oncology Department, General Regional Hospital F. Miulli, Strada Provinciale 127, Acquaviva delle fonti (BA), 70020, Italy. Email: a.fiorentino@miulli.it 933672TMJ 0 0 10.1177/0300891620933672Tumori JournalScarcia et al. editorial 2020 Editorial