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

Sponsor

Sun Yat-sen University (Other)

Overall Status

Unknown status

CT.gov ID

NCT01762514

Collaborator

Dalian Merro Pharmaceutical Co. Ltd (Other)

360

Enrollment

Locations

Arms

Duration (Months)

51.4

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

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

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Jun 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Effect on improving myelosuppression [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 [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 [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). [One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy]
Effect on improving Karnofsky Performance Scores (KPS) [One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy]
Incidence and severity of Nausea [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 [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 [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 [One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy]
One of the adverse effects of Amifostine.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	The Main Guangzhou Hospital of the Guangzhou Military Region	Guangzhou	Guangdong	China	510010
2	Department of Radiation Oncology, Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong	China	510060
3	The Affiliated Cancer Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong	China	510095
4	Guangdong Provincial Hospital Of Chinese Medicine	Guangzhou	Guangdong	China	510120
5	The First Affiliated Hospital Of Guangzhou Medical Collage	Guangzhou	Guangdong	China	510120
6	The Second Affiliated Hospital, Sun Yat-Sen University	Guangzhou	Guangdong	China	510260
7	Guangdong Second People's Hospital	Guangzhou	Guangdong	China	510317