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
18 Years
75 Years
Both
Nasopharyngeal Neoplasms, Salivary Gland Diseases, Bone Marrow Diseases, Mucositis
Trial Information
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.
Inclusion Criteria:
- Nasopharyngeal cancer patients diagnosed by pathology or cytology
- UICC/AJCC 2010 Stage T1-4 N0-3 M0
- Male or female patients with age between 18 and 75 years old
- Karnofsky Performance Scores ≥ 60
- Expected survival ≥ 3 months
- Without dysfunction of heart, lung, liver, kidney and hematopoiesis
- No previous allergic reaction to the drug
Exclusion Criteria:
- History of alcohol or drug abuse within 3 months
- Pregnant or lactating women
- Currently under treatment with other similar drugs
- Anti-hypertension drugs applied in less than 24 hours
- Severe hypocalcemia
- Dysfunction of heart, lung, liver, kidney or hematopoiesis
- Severe neurological, mental or endocrine diseases
- Previous allergic reaction to the drug
- Patients participated in clinical trials of other drugs within last 3 months
- Other unsuitable reason
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Outcome Measure:
Effect on improving myelosuppression
Outcome Description:
Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
Outcome Time Frame:
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Safety Issue:
No
Principal Investigator
Yun-fei Xia, Prof.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
Authority:
China: Food and Drug Administration
Study ID:
AMF-BYA-02
NCT ID:
NCT01762514
Start Date:
January 2013
Completion Date:
June 2014
Related Keywords:
- Nasopharyngeal Neoplasms
- Salivary Gland Diseases
- Bone Marrow Diseases
- Mucositis
- Nasopharyngeal carcinoma
- Amifostine
- Myelosuppression
- Xerostomia
- Mucositis
- Bone Marrow Diseases
- Neoplasms
- Nasopharyngeal Neoplasms
- Salivary Gland Diseases
- Mucositis
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