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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00274937




Registration number
NCT00274937
Ethics application status
Date submitted
10/01/2006
Date registered
11/01/2006
Date last updated
25/10/2022

Titles & IDs
Public title
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Scientific title
Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Secondary ID [1] 0 0
NCI-2009-00412
Secondary ID [2] 0 0
ARAR0331
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 0 0
Stage I Nasopharyngeal Undifferentiated Carcinoma AJCC v7 0 0
Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 0 0
Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7 0 0
Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 0 0
Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 0 0
Stage IV Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 0 0
Stage IV Nasopharyngeal Undifferentiated Carcinoma AJCC v7 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Amifostine
Treatment: Drugs - Cisplatin
Treatment: Drugs - Fluorouracil
Other interventions - Laboratory Biomarker Analysis
Treatment: Other - Radiation Therapy

Experimental: Stratum I (radiotherapy, chemoprotective agent) - Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.

Experimental: Stratum II (chemotherapy, chemoprotective agent, radiotherapy) - 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 weeks 10-18, patients undergo radiotherapy and receive amifostine as in stratum I. Patients also receive 3 courses of cisplatin as before.


Treatment: Drugs: Amifostine
Given subcutaneously

Treatment: Drugs: Cisplatin
Given IV

Treatment: Drugs: Fluorouracil
Given IV

Other interventions: Laboratory Biomarker Analysis
Correlative studies

Treatment: Other: Radiation Therapy
Undergo radiotherapy
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Intervention code [3] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Two Year Event-free Survival (EFS)
Timepoint [1] 0 0
Up to Two Year After Enrollment
Secondary outcome [1] 0 0
Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment
Timepoint [1] 0 0
At study enrollment
Secondary outcome [2] 0 0
Prognostic Significance of EBV Viral Load
Timepoint [2] 0 0
At study enrollment
Secondary outcome [3] 0 0
Predictive Value of the Detection of EBV DNA in the Peripheral Blood
Timepoint [3] 0 0
Up to 6 years
Secondary outcome [4] 0 0
Protective Effects of Amifostine Assessed Primarily by Sialometry
Timepoint [4] 0 0
At study enrollment
Secondary outcome [5] 0 0
Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
Timepoint [5] 0 0
At study enrollment

Eligibility
Key inclusion criteria
- Histological diagnosis of nasopharyngeal carcinoma WHO type II or III

- Stage I-IV disease

- Newly diagnosed disease

- 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

- Creatinine based on age/gender as follows:

- No greater than 0.4 mg/dL (for patients 1 month to < 6 months of age)

- No greater than 0.5 mg/dL (for patients 6 months to < 1 year of age)

- No greater than 0.6 mg/dL (for patients 1-2 years of age)

- No greater than 0.8 mg/dL (for patients < 6 years of age)

- No greater than 1.0mg/dL (for patients 6 to < 10 years of age)

- No greater than 1.2 mg/dL (for patients 10 to < 13 years of age)

- No greater than 1.4 mg/dL (for female patients 13 to = 16 years of age)

- No greater than 1.5 mg/dL (for male patients 13 to < 16 years of age)

- No greater than 1.7 mg/dL (for male patients = 16 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

- No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of
nasopharyngeal carcinoma
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2022
Sample size
Target
Accrual to date
Final
111
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Princess Margaret Hospital for Children - Perth
Recruitment postcode(s) [1] 0 0
6008 - Perth
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Arkansas
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California
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Colorado
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Connecticut
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District of Columbia
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Florida
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Georgia
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Hawaii
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Illinois
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Indiana
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Kentucky
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Louisiana
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Maryland
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Michigan
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Minnesota
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Jersey
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Oklahoma
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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West Virginia
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Wisconsin
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Nova Scotia
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Canada
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Ontario
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Canada
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Quebec
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Canada
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Saskatchewan

Funding & Sponsors
Primary sponsor type
Other
Name
Children's Oncology Group
Address
Country
Other collaborator category [1] 0 0
Government body
Name [1] 0 0
National Cancer Institute (NCI)
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy
work in treating young patients with newly diagnosed nasopharyngeal cancer. 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00274937
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Carlos Rodriguez-Galindo
Address 0 0
Children's Oncology Group
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00274937