Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study |
- Disease-free survival (EFS) [ Time Frame: At 2 years ] [ Designated as safety issue: No ]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%. Confidence intervals for the estimated two year EFS will be provided. The one-sample one-sided log-rank test comparing the observed data with the hypothesized model of size 0.05 will be used to assess whether the data are consistent with the target model. The method of Lan and DeMets will be used to derive the p-values for testing procedure.
- Predictive value of Epstein-Barr virus (EBV) DNA as measured by quantitative detection at 2 years after treatment [ Time Frame: Not Provided ] [ Designated as safety issue: No ]
- Prognostic significance of EBV viral load [ Time Frame: At baseline ] [ Designated as safety issue: No ]The assessment of the prognostic significance of EBV changes and risk for clinical events will be conducted using survival analysis techniques.
- Predictive value of the detection of EBV DNA in the peripheral blood [ Time Frame: Up to 6 years ] [ Designated as safety issue: No ]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.
- Protective effects of amifostine assessed primarily by sialometry [ Time Frame: At baseline and up to 12 weeks after completion of radiotherapy ] [ Designated as safety issue: No ]The difference in the total amount of saliva collected at study enrollment will be subtracted from the total amount of saliva collected at the end of treatment, after adjustment for the collection time at each time point. A Wilcoxon test logrank test of size 0.05 of the null hypothesis of 0 median change in amount of saliva collected will be used to assess the protective effect of amifostine.
| Enrollment: | 111 |
| Study Start Date: | February 2006 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Stratum I (radiotherapy, chemoprotective agent)
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:
Other: laboratory biomarker analysis
Correlative studies
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
|
|
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 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:
Drug: fluorouracil
Given IV
Other Names:
Drug: cisplatin
Given IV
Other Names:
Other: laboratory biomarker analysis
Correlative studies
Radiation: radiation therapy
Undergo radiotherapy
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | up to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00274937
Show 91 Study Locations
| Principal Investigator: | Carlos Rodriguez-Galindo, MD | Children's Oncology Group |
More Information
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00274937 History of Changes |
| Other Study ID Numbers: | ARAR0331, NCI-2009-00412, COG-ARAR0331, CDR0000454849, U10CA098543 |
| Study First Received: | January 10, 2006 |
| Last Updated: | February 28, 2014 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Carcinoma Carcinoma, Squamous Cell Nasopharyngeal Neoplasms Head and Neck Neoplasms Nasopharyngeal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases |
Amifostine Cisplatin Fluorouracil Antimetabolites Antimetabolites, Antineoplastic Antineoplastic Agents Immunologic Factors Immunosuppressive Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protective Agents Radiation-Protective Agents Radiation-Sensitizing Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015