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

Overview

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 Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2019

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • No Intervention: Program I
    • Patients with American Joint Cancer Committee/Union Internationale Contre le Cancer (UICC/AJCC) 2010 Stage I and II; Radiotherapy applied
  • Experimental: Program II
    • Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen
  • Active Comparator: Program III
    • Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen
  • No Intervention: Program IV
    • Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied
  • Experimental: Program V
    • Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen
  • Active Comparator: Program VI
    • Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen

Clinical Trial Outcome Measures

Primary Measures

  • Effect on improving myelosuppression
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • Severity of myelosuppression is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) 4.0 criteria.
  • Effect on improving xerostomia
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • Severity of xerostomia is evaluated on basis of CTCAE 4.0 criteria.
  • Effect on improving mucositis
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • Severity of mucositis is evaluated on basis of CTCAE 4.0 criteria.

Secondary Measures

  • Effect on improving Quality of Life (QOL).
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
  • Effect on improving Karnofsky Performance Scores (KPS)
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
  • Incidence and severity of Nausea
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • One of the adverse effects of Amifostine.
  • Incidence and severity of Vomiting
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • One of the adverse effects of Amifostine.
  • Incidence and severity of Hypotension
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • One of the adverse effects of Amifostine.
  • Incidence and severity of Hypocalcemia
    • Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
    • One of the adverse effects of Amifostine.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sun Yat-sen University
  • Collaborator
    • Dalian Merro Pharmaceutical Co. Ltd
  • Provider of Information About this Clinical Study
    • Principal Investigator: Yun-fei Xia, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center – Sun Yat-sen University
  • Overall Official(s)
    • Yun-fei Xia, Prof., Principal Investigator, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
  • Overall Contact(s)
    • Yun-fei Xia, Prof., +86-13602805461, xiayf@hotmail.com

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