A Multi-institutional, Randomized Parallel Controlled, Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Amifostine Every-other-day Regimen and Everyday Regimen From Monday to Friday
RATIONALE: Nasopharyngeal carcinoma is a kind of malignant tumor which is treated primarily
by radiation therapy. This therapeutic strategy often causes adverse effects such as
dysfunction of salivary gland and lesion of oral mucosa. With concurrent chemotherapy, it
may also cause toxicity to kidney, bone marrow, and other organs or tissues. When
administered prior to chemoradiotherapy, Amifostine has been proved to has the ability of
protecting the normal from these adverse effects so as to improve the patient tolerance.
However, there are also some side effects of Amifostine itself, such as nausea, vomiting and
hypotension, especially when high dose is applied.
PURPOSE: This phase II randomized controlled trial is to study the protecting effect and its
safety of Amifostine every-other-day regimen compared with standard everyday regimen on
adverse effects such as myelosuppression, xerostomia and mucositis, in patients with
nasopharyngeal carcinoma Stage T1-T4, N0-N3, M0 and undergoing concurrent chemoradiotherapy.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Effect on improving myelosuppression
Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Yun-fei Xia, Prof.
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
China: Food and Drug Administration