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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Sun Yat-sen University
Sponsor:
Collaborator:
Dalian Merro Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Yun-fei Xia, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01762514
First received: December 22, 2012
Last updated: July 2, 2013
Last verified: July 2013
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence and severity of Nausea [ Time Frame: One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    One of the adverse effects of Amifostine.


Estimated Enrollment: 360
Study Start Date: January 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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 Second Affiliated Hospital, Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510260
Contact: Yi-min Liu, Prof.    +86-13802501812    liuyimincn@139.com   
Principal Investigator: Yi-min Liu, Prof.         
The Affiliated Cancer Hospital Of Guangzhou Medical Collage Not yet recruiting
Guangzhou, Guangdong, China, 510095
Contact: Xun-fan Shao, Prof.    +86-13902770926    xunfanshao@yahoo.com.cn   
Principal Investigator: Xun-fan Shao, Prof.         
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 Main Guangzhou Hospital of the Guangzhou Military Region Recruiting
Guangzhou, Guangdong, China, 510010
Contact: Jing Li, Prof.    +86-13503078741    jameslijing@163.com   
Principal Investigator: Jing Li, Prof.         
Guangdong Second People's Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510317
Contact: Wei-shu Song, Prof.    +86-13602806591      
Principal Investigator: Wei-shu Song, Prof.         
Guangdong Provincial Hospital Of Chinese Medicine Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Gong Li, Prof.    +86-13802915171    leegong@21cn.com   
Principal Investigator: Gong Li, Prof.         
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

No publications provided

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
Study First Received: December 22, 2012
Last Updated: July 2, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Sun Yat-sen University:
Nasopharyngeal carcinoma
Amifostine
Myelosuppression
Xerostomia
Mucositis

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

ClinicalTrials.gov processed this record on July 31, 2014