Mucositis Clinical Trial
Official title:
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
- Radiotherapy is the primary therapeutic strategy for nasopharyngeal carcinoma.
- Radiotherapy may cause adverse effect such as xerostomia and mucositis.
- Amifostine has the ability of protecting the normal tissue but also has some side
effects.
PURPOSE
- This phase II trial is to study the protecting effect and safety of different Amifostine
regimens in patients with nasopharyngeal carcinoma.
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.
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