Nal-IRI/LV5-FU versus paclitaxel as second-line therapy in patients with metastatic esophageal squamous cell carcinoma (OESIRI)-PRODIGE 62: A multicentre,randomised, non-comparative phase II study |
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| Affiliation: | 1. Gastroenterology Department, Centre Hospitalo-Universitaire de Poitiers, University of Poitiers, Poitiers, France;2. Medical Oncology Department, Institut Régional Du Cancer de Montpellier (ICM), Université de Montpellier, France;3. Medical Oncology Department, Hôpital Privé Jean du Cancer de Mermoz, Lyon, France;4. FFCD EPICAD INSERM LNC-UMR 1231, University of Burgundy and Franche-Comté, Dijon, France;5. Medical Oncology Department, Centre Henri Becquerel, Rouen, France;6. Gastroenterology Department, Centre Hospitalo-Universitaire Pontchaillou, Rennes 1 University, Rennes, France;7. Digestive Oncology Department, AP-HM, La Timone Hospital, Aix-Marseille Université, Marseille, France;8. Biology Department, Assistance Publique-Hôpitaux de Paris, European Georges Pompidou Hospital, Paris, France;9. Digestive Oncology Department, Institut Sainte Catherine, Avignon, France;10. Gastroenterology Department, Hôpitaux Civils, Colmar, France;11. Gastroenterology & Digestive Oncology Department, Centre Hospitalo-Universitaire d’Angers, Angers, France;12. Gastroenterology Department, Centre Hospitalier Sud Francilien, Corbeil-Essonnes, France;13. Gastroenterology Department, Groupe Hospitalier Nord Essonne, Longjumeau, France;14. Gastroenterology and Hepatology Department, Centre Hospitalo-Universitaire de Nancy, Vandoeuvre-lès-Nancy, France;15. Medical Oncology Department, Institut Mutualiste Montsouris, Paris, France;p. Medical Oncology Department, Centre Hospitalo-Universitaire de Besançon, Besançon, France;q. Medical Oncology Department, Centre Hospitalier Régional Universitaire de Brest-Hôpital Morvan, Brest, France;r. Gastroenterology Department, Centre Hospitalier de La Roche-sur-Yon, La Roche-sur-Yon, France;s. Gastroenterology Department, Centre Hospitalo-Universitaire de Dijon, EPICAD INSERM LNC-UMR 1231, University of Bourgogne-Franche Comté, Dijon, France |
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| Abstract: | Half of patients newly diagnosed with esophageal squamous cell cancer (ESCC) have metastatic disease (mESCC) and therefore a poor prognosis. Furthermore, half of patients with initial loco-regional disease present disease recurrence after surgery and/or chemoradiation. In mESCC, the recommended first-line treatment combines 5-fluorouracil and cisplatin, although this has not been validated by a phase III trial. Patients with disease progression or recurrence after platinum-based chemotherapy and good performance status probably benefit from second-line chemotherapy. Several molecules have been evaluated in phase I/II trials or retrospective studies (docetaxel, paclitaxel and irinotecan) but no randomised studies are available.OESIRI is a multicentre, randomised, open-label phase II trial designed to evaluate efficacy and safety of liposomal irinotecan (nal-IRI) plus 5-FU versus paclitaxel as second-line therapy in patients with mESCC. The main inclusion criteria are histologically proven mESCC in progression after first-line platinum-based chemotherapy. Patients with initial resectable disease can be included if recurrence occurred within 6 months.The primary objective is to evaluate the percentage of patients alive 9 months after randomisation. Secondary endpoints are progression-free survival, overall survival, response rate, safety and quality of life. In addition, circulating tumour DNA will be monitored to assess its prognostic value. |
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| Keywords: | Esophageal cancer Irinotecan Paclitaxel Squamous cell cancer |
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