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

This study is currently recruiting participants.
Verified July 2017 by Yun-fei Xia, Sun Yat-sen University
Sponsor:
ClinicalTrials.gov Identifier:
NCT01762514
First Posted: January 7, 2013
Last Update Posted: July 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Dalian Merro Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Yun-fei Xia, Sun Yat-sen University
  Purpose

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.

Condition Intervention Phase
Nasopharyngeal Neoplasms Salivary Gland Diseases Bone Marrow Diseases Mucositis Drug: Amifostine every-other-day regimen Drug: Amifostine everyday regimen Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Yun-fei Xia, Sun Yat-sen University:

Primary Outcome 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 Outcome 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.


Estimated Enrollment: 360
Study Start Date: January 2013
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: June 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Amifostine administered 5 times per week regimen

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01762514


Contacts
Contact: Yun-fei Xia, Prof. +86-13602805461 xiayf@hotmail.com
Contact: Hui Chang, M.D. +86-13480295989 changhui@sysucc.org.cn

Locations
China, Guangdong
The Main Guangzhou Hospital of the Guangzhou Military Region Suspended
Guangzhou, Guangdong, China, 510010
Department of Radiation Oncology, Sun Yat-Sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Yun-fei Xia, Prof.    +86-13602805461    xiayf@hpotmail.com   
Contact: Hui Chang, M.D.    +86-13480295989    changhui@sysucc.org.cn   
Principal Investigator: Yun-fei Xia, Prof.         
Sub-Investigator: Hui Chang, M.D.         
Sub-Investigator: Zhi-gang Liu, M.D.         
The Affiliated Cancer Hospital Of Guangzhou Medical Collage Suspended
Guangzhou, Guangdong, China, 510095
Guangdong Provincial Hospital Of Chinese Medicine Suspended
Guangzhou, Guangdong, China, 510120
The First Affiliated Hospital Of Guangzhou Medical Collage Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Dao-li Niu, Prof.    +86-13711101855    daoliniu@163.com   
Principal Investigator: Dao-li Niu, Prof.         
The Second Affiliated Hospital, Sun Yat-Sen University Suspended
Guangzhou, Guangdong, China, 510260
Guangdong Second People's Hospital Withdrawn
Guangzhou, Guangdong, China, 510317
Sponsors and Collaborators
Sun Yat-sen University
Dalian Merro Pharmaceutical Co. Ltd
Investigators
Principal Investigator: Yun-fei Xia, Prof. Department of Radiation Oncology, Sun Yat-Sen University Cancer Center
  More Information

Responsible Party: Yun-fei Xia, Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01762514     History of Changes
Other Study ID Numbers: AMF-BYA-02
First Submitted: December 22, 2012
First Posted: January 7, 2013
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Yun-fei Xia, Sun Yat-sen University:
Nasopharyngeal carcinoma
Amifostine
Myelosuppression
Xerostomia
Mucositis

Additional relevant MeSH terms:
Nasopharyngeal Neoplasms
Mucositis
Bone Marrow Diseases
Salivary Gland Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Hematologic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Nasopharyngeal Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Amifostine
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs


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