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

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ClinicalTrials.gov Identifier: NCT00274937
Recruitment Status : Completed
First Posted : January 11, 2006
Results First Posted : January 19, 2017
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Stage I Lymphoepithelioma of the Nasopharynx Stage I Squamous Cell Carcinoma of the Nasopharynx Stage II Lymphoepithelioma of the Nasopharynx Stage II Squamous Cell Carcinoma of the Nasopharynx Stage III Lymphoepithelioma of the Nasopharynx Stage III Squamous Cell Carcinoma of the Nasopharynx Stage IV Lymphoepithelioma of the Nasopharynx Stage IV Squamous Cell Carcinoma of the Nasopharynx Drug: amifostine trihydrate Drug: fluorouracil Drug: cisplatin Other: laboratory biomarker analysis Radiation: radiation therapy Phase 3

Detailed Description:

PRIMARY OBJECTIVES:

I. Determine the response rate, overall survival, and event-free survival of children with advanced nasopharyngeal carcinoma who are treated with induction chemotherapy followed by concurrent chemoradiotherapy and amifostine.

SECONDARY OBJECTIVES:

I. Characterize the role of Epstein-Barr virus (EBV) in the pathogenesis of nasopharyngeal carcinoma in children.

II. Investigate the predictive value of the detection of EBV DNA in the peripheral blood of children with nasopharyngeal carcinoma.

III. Determine the incidence of NUT rearrangements in childhood nasopharyngeal carcinoma.

IV. Determine the radioprotective effect of amifostine when given daily prior to radiation therapy.

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.

STRATUM II:

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 cisplatin IV over 6 hours on days 1 and 22 (2 courses).

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


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
Study Start Date : February 2006
Actual Primary Completion Date : March 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Stratum I - AJCC Stages I-IIa
Patients undergo radiation therapy 5 days a week for 8 weeks. Patients also receive amifostine trihydrate subcutaneously on the same days they undergo radiation therapy.
 Drug: amifostine trihydrate
Given subcutaneously
Other Names:
  • ethiofos
  • Ethyol
  • gammaphos
  • WR-2721

Other: laboratory biomarker analysis
Correlative studies

Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation
Experimental: Stratum II - AJCC Stages IIb-IV
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 radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.
 Drug: amifostine trihydrate
Given subcutaneously
Other Names:
  • ethiofos
  • Ethyol
  • gammaphos
  • WR-2721

Drug: fluorouracil
Given IV
Other Names:
  • 5-fluorouracil
  • 5-Fluracil
  • 5-FU

Drug: cisplatin
Given IV
Other Names:
  • CACP
  • CDDP
  • CPDD
  • DDP

Other: laboratory biomarker analysis
Correlative studies

Radiation: radiation therapy
Undergo radiotherapy
Other Names:
  • irradiation
  • radiotherapy
  • therapy, radiation


Outcome Measures
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Primary Outcome Measures :
  1. Two Year Event-free Survival (EFS) [ Time Frame: Up to Two Year After Enrollment ]
    The two-year event-free survival will be compared with a standard established from adult oncology data and the results of POG-9486. The two-year Kaplan-Meier estimate of event-free survival will be compared with 70% using a 1-sided test of size 0.05 using the asymptotic distribution of the complementary log-log distribution of the estimate.


Secondary Outcome Measures :
  1. Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment [ Time Frame: At study enrollment ]
    Presence of EBV DNA in serum.

  2. Prognostic Significance of EBV Viral Load [ Time Frame: At study enrollment ]
    Viral load in blood.

  3. Predictive Value of the Detection of EBV DNA in the Peripheral Blood [ Time Frame: Up to 6 years ]
    The prognostic value of the presence of EBV DNA will be assessed using the log-rank test, adjusted by initial stage of disease, if appropriate. The proposed analysis will take place at the analytic endpoint of the clinical trial.

  4. Protective Effects of Amifostine Assessed Primarily by Sialometry [ Time Frame: At study enrollment ]
    Weight of stimulated saliva production in grams.

  5. Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams. [ Time Frame: At study enrollment ]
    Weight of unstimulated saliva production in grams.


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00274937


  Show 91 Study Locations
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Carlos Rodriguez-Galindo, MD Children's Oncology Group
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT00274937     History of Changes
Other Study ID Numbers: ARAR0331
NCI-2009-00412 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
COG-ARAR0331 ( Other Identifier: Children's Oncology Group )
CDR0000454849 ( Other Identifier: Clinical Trials.gov )
U10CA098543 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2006    Key Record Dates
Results First Posted: January 19, 2017
Last Update Posted: June 8, 2017
Last Verified: May 2017

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
 Otorhinolaryngologic Diseases
Cisplatin
Fluorouracil
Amifostine
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Protective Agents
Protective Agents