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

Sun Yat-sen University

Status and phase: Unknown; Phase 2

Conditions: Bone Marrow Diseases; Mucositis; Salivary Gland Diseases; Nasopharyngeal Neoplasms

Treatments: Drug: Amifostine every-other-day regimen; Drug: Amifostine everyday regimen

Study type: Interventional

Funder types: Other

Identifiers

NCT01762514

AMF-BYA-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 6 patient groups

Program I

No Intervention group

Description:

Patients with American Joint Cancer Committee/Union Internationale Contre le Cancer (UICC/AJCC) 2010 Stage I and II; Radiotherapy applied

Program II

Experimental group

Description:

Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen

Treatment:

Drug: Amifostine every-other-day regimen

Program III

Active Comparator group

Description:

Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen

Treatment:

Drug: Amifostine everyday regimen

Program IV

No Intervention group

Description:

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied

Program V

Experimental group

Description:

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen

Treatment:

Drug: Amifostine every-other-day regimen

Program VI

Active Comparator group

Description:

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen

Treatment:

Drug: Amifostine everyday regimen