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

July 11, 2017 updated by: Yun-fei Xia, Sun Yat-sen University

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Hui Chang, M.D.
        • Sub-Investigator:
          • Zhi-gang Liu, M.D.
      • Guangzhou, Guangdong, China, 510010
        • Suspended
        • The Main Guangzhou Hospital of the Guangzhou Military Region
      • Guangzhou, Guangdong, China, 510095
        • Suspended
        • The Affiliated Cancer Hospital Of Guangzhou Medical Collage
      • Guangzhou, Guangdong, China, 510120
        • Suspended
        • Guangdong Provincial Hospital of Chinese Medicine
      • Guangzhou, Guangdong, China, 510120
        • Recruiting
        • The First Affiliated Hospital Of Guangzhou Medical Collage
      • Guangzhou, Guangdong, China, 510260
        • Suspended
        • The Second Affiliated Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510317
        • Withdrawn
        • Guangdong Second People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
ACTIVE_COMPARATOR: Program III
Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday 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
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
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
ACTIVE_COMPARATOR: Program VI
Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
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.
One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Collaborators

Dalian Merro Pharmaceutical Co. Ltd

Investigators

  • Principal Investigator: Yun-fei Xia, Prof., Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ANTICIPATED)

June 1, 2019

Study Completion (ANTICIPATED)

December 1, 2019

Study Registration Dates

First Submitted

December 22, 2012

First Submitted That Met QC Criteria

January 4, 2013

First Posted (ESTIMATE)

January 7, 2013

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMF-BYA-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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