Clinical trial · Interventional
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
Treatment of Childhood Nasopharyngeal Carcinoma With Neoadjuvant Chemotherapy and Concomitant Chemoradiotherapy: A Groupwide Phase III Study
NCT00274937CI-TRIAL-00061649completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage III Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Nasopharyngeal Keratinizing Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage III Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Nasopharyngeal Keratinizing Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage II Nasopharyngeal Undifferentiated Carcinoma AJCC v7 | Nasopharyngeal Undifferentiated Carcinoma | CURATED_BROADER | 0.78 |
| Stage I Nasopharyngeal Keratinizing Squamous Cell Carcinoma AJCC v7 | Nasopharyngeal Keratinizing Squamous Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Amifostine | Drug | — | UNRESOLVED |
| Cisplatin | Drug | Cisplatin | ALIAS |
| Fluorouracil | Drug | Fluorouracil | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stratum I (radiotherapy, chemoprotective agent)
- description
- Patients undergo radiotherapy 5 days a week for 8 weeks. Patients also receive amifostine subcutaneously on the same days they undergo radiotherapy.
- interventionNames
- Drug: Amifostine
- Other: Laboratory Biomarker Analysis
- Radiation: Radiation Therapy
- type
- EXPERIMENTAL
- label
- Stratum II (chemotherapy, chemoprotective agent, radiotherapy)
- 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.
- interventionNames
- Drug: Amifostine
- Drug: Cisplatin
- Drug: Fluorouracil
- Other: Laboratory Biomarker Analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDJeha 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
- DERIVEDRodriguez-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