Abstract 928TiP
Background
The standard of care for locally advanced nasopharyngeal carcinoma is radical chemoradiation (CRT). Recent advances in radiation techniques and supportive measures resulted in improvement of locoregional control and quality of life. However distant failure is still the main challenging reason of poor survival Addition of systemic therapy to concurrent CRT is widely used and accepted as an option to reduce these failures, however selection of chemotherapy regimen and timing in relation to CRT is controversial. Doublet and triplet chemotherapy regimens using cisplatin and 5FU are thoroughly investigated in this setting. In spite of significant improvement in disease free survival and overall survival they were poorly tolerated. Hence, a minority of patients in the daily practice could tolerate those studied regimens as proposed. Recently, in multicenter randomized trial, Zhang and his group investigated gemcitabine and cisplatin as induction chemotherapy (ICT) added to CRT. It showed improvement in recurrence free survival and overall survival. More importantly 96.7% of the experimental arm completed the treatment protocol. This was further confirmed by an updated network of meta analysis by Bongiovanni et al. Again, the question of "when" is still valid. Our proposal is to compare tolerable regimen in induction versus adjuvant settings.
Trial design
This is a prospective, non-blinded, open label, randomized phase III study. The patients will be randomised to one of two arms: Arm 1: patients will receive three cycles of IC gemcitabine/cisplatin followed by radical CRT Arm 2: Patients will receive radical CRT followed by three cycles of AC gemcitabine/cisplatin Patients fulfilling the eligibility criteria will be randomized either for ICT followed by CRT or CRT followed by ACT. Chemotherapy protocols for either ICT or ACT, 3 cycles of: Cisplatin: 80 mg/m2 Day 1; every 21 days cycle gemcitabine 1000 mg/ m2 Day 1,Day 8; every 21 days cycle. CRT: Intensity Modulated Radiotherapy (IMRT) 70 Gy/ 35 Fractions over 7 weeks with cisplatin 100 mg/m2 every 3 weeks.
Clinical trial identification
ClinicalTrials.gov Protocol Registration and Results System (PRS)
Release Date: May 13, 2021
ClinicalTrials.gov ID: [Not yet assigned]
Editorial acknowledgement
Legal entity responsible for the study
Ministry of Health, Kuwait.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.