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

NCT01762514 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2017-07-13

No results posted yet for this study

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

Interventions

DRUG

Amifostine every-other-day regimen

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

DRUG

Amifostine everyday regimen

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

Sponsors & Collaborators

  • Dalian Merro Pharmaceutical Co. Ltd

    collaborator UNKNOWN
  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yun-fei Xia, Prof. · Department of Radiation Oncology, Sun Yat-Sen University Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2019-06-30
Completion
2019-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01762514 on ClinicalTrials.gov