NCT01762514

A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Nasopharyngeal Neoplasms
• Salivary Gland Diseases
• Bone Marrow Diseases
• Mucositis

Interventions

Type	Name	Description
DRUG	Amifostine every-other-day regimen	Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy
DRUG	Amifostine everyday regimen	Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy

Timeline

• Start date: 2013-01-01
• Primary completion: 2019-06-01
• Completion: 2019-12-01
• First posted: 2013-01-07
• Last updated: 2017-07-13

Locations

7 sites across 1 country: China