ShorTrip Trial: A Prospective,Multicentric Phase II Single-Arm Trial of Short-Course Radiotherapy Followed by Intensified Consolidation Chemotherapy With the Triplet FOLFOXIRI as Total Neoadjuvant Therapy in Locally Advanced Rectal Cancer |
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| Affiliation: | 1. Unit of Medical Oncology 2, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy;2. Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy;3. Radiation Oncology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy;4. General Surgery, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy;5. General Surgery, Department of Translational Research and New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy;6. Cisanello Radiology Unit, Azienda Ospedaliero Universitaria Pisana, Pisa, Italy;7. Oncology Unit 1, Veneto Institute of Oncology IOV - IRCCS, Padua, Italy;8. Medical Oncology Unit, IRST IRCCS, Meldola, Italy;9. Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano, Italy;10. Department of Medical Oncology, Nuovo Ospedale di Prato Santo Stefano, Prato, Italy;11. Oncologia Medica, Comprehensive Cancer Center, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Roma, Italy;12. Oncologia Medica, Università Cattolica del Sacro Cuore, Roma, Italy;13. Medical Oncology Unit, Ospedale Misericordia, Grosseto, Italy;14. Clinical Epidemiology Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy;1. Department of Radiation Oncology, University of Health Sciences, Dr. Lutfi Kirdar Kartal Training and Research Hospital, Istanbul, Turkey;2. Department of Radiation Oncology, Faculty of Medicine, Hacettepe University, Ankara, Turkey;3. Department of Radiation Oncology, Izmir Katip Celebi University, Ataturk Training and Research Hospital, Izmir, Turkey;4. Istanbul University Department of Radiation Oncology, Hospital of Cerrahpasa school of Medicine, Istanbul, Turkey;5. Department of Radiation Oncology, Manisa State Hospital, Manisa, Turkey;6. Department of Radiation Oncology, Izmir Tinaztepe University, Izmir, Turkey;7. Hamidiye International School of Medicine, University of Health Sciences, Istanbul, Turkey;8. Department of Radiation Oncology, Dokuz Eylul University Faculty of Medicine, Izmir, Turkey;1. Department of Thoracic Oncology, Thoraxklinik and National Center for Tumor Diseases at Heidelberg University Hospital, Heidelberg, Germany;2. Translational Lung Research Center (TLRC) Heidelberg, member of the German Center for Lung Research (DZL), Heidelberg, Germany;3. Department of Thoracic Surgery, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany;4. Department of Pharmacy, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany;5. Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany;6. Department of Diagnostic and Interventional Radiology with Nuclear Medicine, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany;7. Department of Diagnostic and Interventional Radiology, University Hospital, Heidelberg, Germany;8. Department of Pneumology, Thoraxklinik, Heidelberg University Hospital, Heidelberg, Germany |
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| Abstract: | BackgroundIn patients with locally advanced rectal cancer (LARC) treated with preoperative (chemo) radiotherapy and surgery, adjuvant chemotherapy is poorly feasible and its benefit is questionable. In the last years, several total neoadjuvant treatment (TNT) strategies, moving the adjuvant chemotherapy to the neoadjuvant setting, have been investigated with the aim of improving compliance to systemic chemotherapy, treating micrometastases earlier and then reducing distant recurrence.Patients and MethodsShorTrip (NTC05253846) is a prospective, multicentre, single-arm phase II trial where 63 patients with LARC will be treated with short-course radiotherapy followed by intensified consolidation chemotherapy with FOLFOXIRI regimen and surgery. Primary endpoint is pCR. Among the first 11 patients who started consolidation chemotherapy, a preliminary safety analysis showed a high rate of grade 3 to 4 neutropenia (N = 7, 64%) during the first cycle of FOLFOXIRI. Therefore, the protocol has been emended with the recommendation to omit irinotecan during the first cycle of consolidation chemotherapy. After amendment, in a subsequent safety analysis focused on the first 9 patients treated with FOLFOX as first cycle and then with FOLFOXIRI, grade 3 to 4 neutropenia was reported in only one case during the second cycle.Aim of the studyThe aim of this study is to assess the safety and activity of a TNT strategy including SCRT, intensified consolidation treatment with FOLFOXIRI and delayed surgery. After protocol amendment, the treatment seems feasible without safety concern. Results are expected at the end of 2024. |
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