drugset / Trial / NCT04019548
Assessment of Swallowing Function and Quality of Life in Oropharyngeal Cancer Patients Treated by Chemo-radiotherapy
RandomizedParallel-groupOpen-labelOther
Summary
Open-label, interventional, multicentric, randomized, phase III study. Cancer studied is the oropharyngeal cancer. Study is composed by 2 arms of subjects: prophylactic or reactive percutaneous endoscopic gastrostomy tube placement. All subjects will be treated with a cisplatin standard chemotherapy regimen and by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT).
Timeline
- Start
- 2019-12-16
- Primary completion
- 2027-11-01
- Completion
- 2030-05-01
Publications
- Van Honacker B, Lefebvre Y, Paesmans M, Burghelea M, Van Gestel D, Dragan T. Dual-energy and perfusion CT for predicting response to chemo-radiotherapy in head and neck cancer: an exploratory study. Front Oncol. 2026 May 5;16:1762607. doi: 10.3389/fonc.2026.1762607. eCollection 2026.
- Dragan T, Van Gossum A, Duprez F, Lalami Y, Lefebvre Y, Mootassim-Billah S, Beauvois S, Gulyban A, Vandekerkhove C, Boegner P, Paesmans M, Ameye L, Digonnet A, Quiriny M, Dequanter D, Lipski S, Willemse E, Rodriguez A, Carlot S, Karaca Y, Lemort M, Emonts P, Al Wardi C, Van Gestel D. Patient-reported outcomes in terms of swallowing and quality of life after prophylactic versus reactive percutaneous endoscopic gastrostomy tube placement in advanced oropharyngeal cancer patients treated with definitive chemo-radiotherapy: Swall PEG study. Trials. 2022 Dec 21;23(1):1036. doi: 10.1186/s13063-022-06991-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cisplatin | Other / unclassified | 40 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |