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

NCT01762514 | Unknown Phase 2 DMC

• 1 other identifier: AMF-BYA-02
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

Nasopharyngeal carcinoma; Amifostine; Myelosuppression; Xerostomia; Mucositis

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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 Outcomes (6)

• 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

• Incidence and severity of Vomiting

  One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

• Incidence and severity of Hypotension

  One week before radiotherapy; Once a week during radiotherapy, up to 7 weeks; Three months after radiotherapy

Study Arms (6)

Program I

NO INTERVENTION

Patients with American Joint Cancer Committee/Union Internationale Contre le Cancer (UICC/AJCC) 2010 Stage I and II; Radiotherapy applied

Program II

EXPERIMENTAL

Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine every-other-day regimen

Drug: Amifostine every-other-day regimen

Program III

ACTIVE COMPARATOR

Patients with UICC/AJCC 2010 Stage I and II; Radiotherapy applied; Amifostine everyday regimen

Drug: Amifostine everyday regimen

Program IV

NO INTERVENTION

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied

Program V

EXPERIMENTAL

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine every-other-day regimen

Drug: Amifostine every-other-day regimen

Program VI

ACTIVE COMPARATOR

Patients with UICC/AJCC 2010 Stage III, IVa and IVb; Concurrent chemoradiotherapy applied; Amifostine everyday regimen

Drug: Amifostine everyday regimen

Interventions

Amifostine every-other-day regimen DRUG

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

Also known as: Amifostine administered 3 times per week regimen

Program II; Program V

Amifostine everyday regimen DRUG

Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy

Also known as: Amifostine administered 5 times per week regimen

Program III; Program VI

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Dalian Merro Pharmaceutical Co. Ltd: collaborator

Study Sites (7)

The Main Guangzhou Hospital of the Guangzhou Military Region

Guangzhou, Guangdong, 510010, China

SUSPENDED

Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

The Affiliated Cancer Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510095, China

SUSPENDED

Guangdong Provincial Hospital Of Chinese Medicine

Guangzhou, Guangdong, 510120, China

SUSPENDED

The First Affiliated Hospital Of Guangzhou Medical Collage

Guangzhou, Guangdong, 510120, China

RECRUITING

The Second Affiliated Hospital, Sun Yat-Sen University

Guangzhou, Guangdong, 510260, China

SUSPENDED

Guangdong Second People's Hospital

Guangzhou, Guangdong, 510317, China

WITHDRAWN

Related Publications (2)

• Liu Y, Shi H, Huang S, Chen X, Zhou H, Chang H, Xia Y, Wang G, Yang X. Early prediction of acute xerostomia during radiation therapy for nasopharyngeal cancer based on delta radiomics from CT images. Quant Imaging Med Surg. 2019 Jul;9(7):1288-1302. doi: 10.21037/qims.2019.07.08.

  PMID: 31448214 DERIVED

• Chang H, Yi W, Wang X, Tao Y, Yang X, Chen C, Zhang W, Zhou S, Liu S, Li X, Ding S, Li J, Li G, Shao X, Liu Y, Song W, Xia Y. Effectiveness and safety of different amifostine regimens: Preliminary results of a phase II multicenter randomized controlled trial. Chin J Cancer Res. 2018 Jun;30(3):307-314. doi: 10.21147/j.issn.1000-9604.2018.03.03.

  PMID: 30046225 DERIVED

MeSH Terms

Conditions

Nasopharyngeal Neoplasms; Salivary Gland Diseases; Bone Marrow Diseases; Mucositis; Nasopharyngeal Carcinoma; Xerostomia

Condition Hierarchy (Ancestors)

Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Yun-fei Xia, Prof.

  Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yun-fei Xia, Prof.

CONTACT

+86-13602805461; xiayf@hotmail.com

Hui Chang, M.D.

CONTACT

+86-13480295989; changhui@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Study Record Dates

• First Submitted: December 22, 2012
• First Posted: January 7, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 13, 2017

Record last verified: 2017-07

Locations

CN (7)