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NCT00274937 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2022-10-25

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Two Year Event-free Survival (EFS)

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outcome · POSTED

Predictive Value of Epstein-Barr Virus (EBV) DNA as Measured by Quantitative Detection at Enrollment on EFS 2 Years After Treatment

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outcome · POSTED

Prognostic Significance of EBV Viral Load

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outcome · POSTED

Predictive Value of the Detection of EBV DNA in the Peripheral Blood

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outcome · POSTED

Protective Effects of Amifostine Assessed Primarily by Sialometry

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outcome · POSTED

Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
maximum Age
18 Years
sex
ALL
std Ages
  1. CHILD
  2. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
    intervention Names
    1. Drug: Amifostine
    2. Other: Laboratory Biomarker Analysis
    3. Radiation: Radiation Therapy
    label
    Stratum I (radiotherapy, chemoprotective agent)
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Drug: Amifostine
    2. Drug: Cisplatin
    3. Drug: Fluorouracil
    4. Other: Laboratory Biomarker Analysis
    5. Radiation: Radiation Therapy
    label
    Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Stratum I (radiotherapy, chemoprotective agent)
    2. Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    description
    Given subcutaneously
    name
    Amifostine
    other Names
    1. Amifostine Trihydrate
    2. Aminopropylaminoethylthiophosphoric Acid Trihydrate
    3. APAETP
    4. Cytofos
    5. Ethiofos
    6. Ethyol
    7. Gammaphos
    8. WR 2721
    9. WR-2721
    10. WR2721
    11. YM-08310
    type
    DRUG
  2. arm Group Labels
    1. Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    description
    Given IV
    name
    Cisplatin
    other Names
    1. Abiplatin
    2. Blastolem
    3. Briplatin
    4. CDDP
    5. Cis-diammine-dichloroplatinum
    6. Cis-diamminedichloridoplatinum
    7. Cis-diamminedichloro Platinum (II)
    8. Cis-diamminedichloroplatinum
    9. Cis-dichloroammine Platinum (II)
    10. Cis-platinous Diamine Dichloride
    11. Cis-platinum
    12. Cis-platinum II
    type
    DRUG
  3. arm Group Labels
    1. Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    description
    Given IV
    name
    Fluorouracil
    other Names
    1. 5 Fluorouracil
    2. 5 Fluorouracilum
    3. 5 FU
    4. 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
    5. 5-Fluorouracil
    6. 5-Fluracil
    7. 5-Fu
    8. 5FU
    9. AccuSite
    10. Carac
    11. Fluoro Uracil
    12. Fluouracil
    type
    DRUG
  4. arm Group Labels
    1. Stratum I (radiotherapy, chemoprotective agent)
    2. Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    description
    Correlative studies
    name
    Laboratory Biomarker Analysis
    type
    OTHER
  5. arm Group Labels
    1. Stratum I (radiotherapy, chemoprotective agent)
    2. Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
    description
    Undergo radiotherapy
    name
    Radiation Therapy
    other Names
    1. Cancer Radiotherapy
    2. ENERGY_TYPE
    3. Irradiate
    4. Irradiated
    5. Irradiation
    6. Radiation
    7. Radiation Therapy, NOS
    8. Radiotherapeutics
    9. Radiotherapy
    10. RT
    11. Therapy, Radiation
    type
    RADIATION
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
111
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Two Year Event-free Survival (EFS)
    time Frame
    Up to Two Year After Enrollment
secondary Outcomes
  1. description
    Presence of EBV DNA in serum.
    measure
    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
  2. description
    Viral load in blood.
    measure
    Prognostic Significance of EBV Viral Load
    time Frame
    At study enrollment
  3. description
    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.
    measure
    Predictive Value of the Detection of EBV DNA in the Peripheral Blood
    time Frame
    Up to 6 years
  4. description
    Weight of stimulated saliva production in grams.
    measure
    Protective Effects of Amifostine Assessed Primarily by Sialometry
    time Frame
    At study enrollment
  5. description
    Weight of unstimulated saliva production in grams.
    measure
    Protective Effects of Amifostine Assessed Primarily by Sialometry: Weight of Unstimulated Saliva Production in Grams.
    time Frame
    At study enrollment
Full study description
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.
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.
Source references
references
  1. citation
    Jeha S, Pei D, Choi J, Cheng C, Sandlund JT, Coustan-Smith E, Campana D, Inaba H, Rubnitz JE, Ribeiro RC, Gruber TA, Raimondi SC, Khan RB, Yang JJ, Mullighan CG, Downing JR, Evans WE, Relling MV, Pui CH. Improved CNS Control of Childhood Acute Lymphoblastic Leukemia Without Cranial Irradiation: St Jude Total Therapy Study 16. J Clin Oncol. 2019 Dec 10;37(35):3377-3391. doi: 10.1200/JCO.19.01692. Epub 2019 Oct 28.
    pmid
    31657981
    type
    DERIVED
  2. citation
    Rodriguez-Galindo C, Krailo MD, Krasin MJ, Huang L, McCarville MB, Hicks J, Pashankar F, Pappo AS. Treatment of Childhood Nasopharyngeal Carcinoma With Induction Chemotherapy and Concurrent Chemoradiotherapy: Results of the Children's Oncology Group ARAR0331 Study. J Clin Oncol. 2019 Dec 10;37(35):3369-3376. doi: 10.1200/JCO.19.01276. Epub 2019 Sep 25.
    pmid
    31553639
    type
    DERIVED
see Also Links
  1. label
    Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive
Source notices and limitations
    Discovery and provenance
    1. release id
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      edge id
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      clinical indication matching status
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        exact text
        NCT00274937
        start
        0
      offset unit
      unicode_code_points
      query cond
      Childhood Nasopharyngeal Cancer
      query disease state id
      ds-nasopharyngeal-cancer-pediatric
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-childhood-nasopharyngeal-cancer-000.json
      source file sha256
      a98508ccb50c1cc369ae57ded35696a8dd913c17655cbcad1644379c4d9e5468
      source json pointer
      /studies/0/protocolSection/identificationModule/nctId
      source kind
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      source string sha256
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    Preserved source evidence · Not medical advice