A Phase II Clinical Trial on Comparison of Effectiveness and Safeness of Different Amifostine Regimens
NCT01762514 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2017-07-13
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.
Conditions
- Nasopharyngeal Neoplasms
- Salivary Gland Diseases
- Bone Marrow Diseases
- Mucositis
Interventions
- 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
Sponsors & Collaborators
-
Dalian Merro Pharmaceutical Co. Ltd
collaborator UNKNOWN -
Sun Yat-sen University
lead OTHER
Principal Investigators
-
Yun-fei Xia, Prof. · Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-01-31
- Primary Completion
- 2019-06-30
- Completion
- 2019-12-31
Countries
- China
Study Locations
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