GoldBamboo.com - Knowledge is strong medicine
  

Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer - Article


  Not Signed In - Sign In / Register






Cancer Radiation Therapy


Clinical Trial: Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer

This study is not yet open for patient recruitment.
Verified by National Cancer Institute (NCI) December 2005

Sponsors and Collaborators: Children''''s Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00274937

Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.

PURPOSE: This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer.

Condition Intervention Phase
Nasopharyngeal Cancer
Oral Complications of Chemotherapy and Head and Neck Radiation
 Drug: amifostine trihydrate
 Drug: cisplatin
 Drug: fluorouracil
 Procedure: chemotherapy
 Procedure: complications of therapy assessment/management
 Procedure: neoadjuvant therapy
 Procedure: radiation therapy
 Procedure: radioprotection
 Procedure: supportive care/therapy
Phase III

MedlinePlus related topics:  Cancer;   Head and Neck Cancer;   Throat Disorders

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Study of Radiotherapy and Amifostine OR Neoadjuvant Induction Chemotherapy Followed By Consolidation Chemoradiotherapy and Amifostine in Children With Newly Diagnosed Nasopharyngeal Carcinoma

Further study details as provided by National Cancer Institute (NCI):

OBJECTIVES:

Primary

Secondary Objectives

  • Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.
  • Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.
  • Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.

OUTLINE: This is a nonrandomized, multicenter study. Patients are stratified according to stage of disease (I or IIA [stratum I] vs IIB-IV [stratum II]).

  • Stratum I: Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
  • Induction therapy (weeks 1-9): Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease proceed to consolidation therapy.
  • Consolidation therapy (weeks 10-18): Patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as in induction therapy.

After completion of study treatment, patients are followed periodically for 10 years.

PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:  up to  18 Years,  Genders Eligible for Study:  Both
Criteria

DISEASE CHARACTERISTICS:

  • Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
  • Stage I-IV disease
  • Newly diagnosed disease

PATIENT CHARACTERISTICS:

  • Performance status
  • Patients ≤ 16 years of age: Lansky 60-100%
  • Patients > 16 years of age: Karnofsky 60-100%
  • Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min OR
  • Creatinine based on age as follows:
  • No greater than 0.8 mg/dL (for patients ≤ 5 years of age)
  • No greater than 1.0 mg/dL (for patients 6-10 years of age)
  • No greater than 1.2 mg/dL (for patients 11-15 years of age)
  • No greater than 1.5 mg/dL (for patients > 15 years of age)
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
  • AST or ALT < 2.5 times ULN for age
  • Not pregnant or nursing
  • Negative pregnancy test.
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Location and Contact Information

Please refer to this study by ClinicalTrials.gov identifier  NCT00274937


Study chairs or principal investigators

Carlos Rodriguez-Galindo, MD,  Study Chair,  St. Jude Children''''s Research Hospital   

More Information

Clinical trial summary from the National Cancer Institute''''s PDQ® database

Study ID Numbers:  CDR0000454849; COG-ARAR0331
Last Updated:  January 10, 2006
Record first received:  January 10, 2006
ClinicalTrials.gov Identifier:  NCT00274937
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2006-01-17


Take control over your directory listings...INSTANTLY

Every day, thousands of users find businesses like yours in the GoldBamboo directory.

Limited Time Offer!!!

For only $50 a year, a savings of 50% off our standard rate:

  • Edit your listing (whenever you want!)
  • Link to your website
  • Choose which categories you are listed in
  • Describe your services

The process will take only a few minutes and consists of 3 easy steps:

1. Register     >     2. Edit Listings     >     3. Publish

Your Company
your street
yourtown, YS 12345
888-888-8888



No Thanks

Popular Treatments

Acne Treatment ADHD Treatment Allergy Treatment Alzheimer's Treatment
Anemia Treatment Arthritis Treatment Asthma Treatment Bipolar Disorder Treatment
Bird Flu Treatment Bladder Cancer Treatment Bladder Control Treatment Blood Pressure Treatment
Brain Tumor Treatment Breast Cancer Treatment Bronchitis Treatment Cancer Treatment
Cancer Alternative Treatment Cataract Treatment Cirrhosis Treatment Colitis Treatment
Colon Cancer Treatment Common Cold Treatment Conjunctivitis Treatment Constipation Treatment
Crohn's Disease Treatment Cystic Fibrosis Treatment Depression Treatment Dermatitis Treatment
Diabetes Treatment Edema Treatment Epilepsy Treatment Erectile Dysfunction Treatment
Fibromyalgia Treatment GERD Treatment Glaucoma Treatment Gout Treatment
Hay Fever Treatment Headache Treatment Heart Disease Treatment Hepatitis Treatment
High Blood Pressure Treatment High Cholesterol Treatment Hives Treatment Hypertension Treatment
Hypoglycemia Treatment IBS Treatment Impotence Treatment Indigestion Treatment
Infertility Treatment Influenza Treatment Insomnia Treatment Lactose Intolerance Treatment
Leukemia Treatment Lung Cancer Treatment Lyme Disease Treatment Macular Degeneration Treatment
Menopause Treatment Migraine Treatment Osteoarthritis Treatment Osteoporosis Treatment
Pancreatic Cancer Treatment PMS Treatment Pneumonia Treatment Prostate Diseases Treatment
Restless Leg Treatment Rheumatoid Arthritis Treatment Sepsis Treatment Sinusitis Treatment
Skin Cancer Treatment Sleep Apnea Treatment Snoring Treatment Stroke Treatment
Testicular Cancer Treatment
GoldBambooTM

Your Integrative Health and Wellness Resource for Cancer Radiation Therapy.

October 6, 2008



Page Updated: September 6, 2005
Disclaimer: All material displayed on the GoldBamboo.com website is provided for educational purposes only. Consult a physician regarding the applicability of any information found on GoldBamboo.com to your symptoms or medical condition.

Massachusetts Law | Home | About Us | Link To Us | Feedback | Disclaimer | Privacy Policy | Terms of Use | Google Co-op | Health Forums

Copyright © 2004-2008 - Gold Bamboo LLC
All rights reserved.

HONcode accreditation seal.

We comply with the HONcode standard for health trust worthy information:
verify here.