Trial | NCT01762514  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    amifostine ...

  • Study Participants

    360
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.
Study Started
Jan 31
2013
Primary Completion
Jun 30
2019
Anticipated
Study Completion
Dec 31
2019
Anticipated
Last Update
Jul 13
2017

Drug Amifostine every-other-day regimen

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

  • Other names: Amifostine administered 3 times per week regimen

Drug Amifostine everyday regimen

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

  • Other names: Amifostine administered 5 times per week regimen

Program I No Intervention

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

Program II Experimental

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

Program III Active Comparator

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

Program IV No Intervention

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

Program V Experimental

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

Program VI Active Comparator

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

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
No Results Posted