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

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborator: Dalian Merro Pharmaceutical Co. Ltd
• Treatments: Amifostine

Criteria

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