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

Mucositis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01762514
• Other study ID #: AMF-BYA-02
• Status: Recruiting
• Phase: Phase 2
• First received: December 22, 2012
• Last updated: July 11, 2017
• Start date: January 2013
• Est. completion date: December 2019

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: Yun-fei Xia, Prof.
• Phone: +86-13602805461
• Email: xiayf[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: December 2019
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Mucositis
• Nasopharyngeal Neoplasms
• Salivary Gland Diseases

Intervention

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

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Guangdong Provincial Hospital Of Chinese Medicine	Guangzhou	Guangdong
China	Guangdong Second People's Hospital	Guangzhou	Guangdong
China	The Affiliated Cancer Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong
China	The Main Guangzhou Hospital of the Guangzhou Military Region	Guangzhou	Guangdong
China	The Second Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Dalian Merro Pharmaceutical Co. Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect on improving myelosuppression	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
Primary	Effect on improving xerostomia	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
Primary	Effect on improving mucositis	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	Effect on improving Quality of Life (QOL).		One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary	Effect on improving Karnofsky Performance Scores (KPS)		One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary	Incidence and severity of Nausea	One of the adverse effects of Amifostine.	One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary	Incidence and severity of Vomiting	One of the adverse effects of Amifostine.	One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary	Incidence and severity of Hypotension	One of the adverse effects of Amifostine.	One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy
Secondary	Incidence and severity of Hypocalcemia	One of the adverse effects of Amifostine.	One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy