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

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

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.

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.

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

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

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

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

Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy

Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy

Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

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

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Chang H, Yi W, Wang X, Tao Y, Yang X, Chen C, Zhang W, Zhou S, Liu S, Li X, Ding S, Li J, Li G, Shao X, Liu Y, Song W, Xia Y. Effectiveness and safety of different amifostine regimens: Preliminary results of a phase II multicenter randomized controlled trial. Chin J Cancer Res. 2018 Jun;30(3):307-314. doi: 10.21147/j.issn.1000-9604.2018.03.03.