Clinical trial · Interventional
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
A Feasibility Study Of Primary Chemotherapy Followed By Concomitant Chemoradiation With And Without Amifostine In Patients With Locally Advanced Undifferentiated Nasopharyngeal Cancer (UNPC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): low accrual
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining radiation therapy with chemotherapy may kill more tumor cells. Giving chemoprotective drugs such as amifostine may protect normal cells from the side effects of chemotherapy and radiation therapy. PURPOSE: Randomized phase II trial to compare the effectiveness of paclitaxel and carboplatin followed by cisplatin plus radiation therapy with or without amifostine in treating patients who have locally advanced cancer of the nasopharynx.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Drug/Agent Toxicity by Tissue/Organ | — | UNRESOLVED | — |
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Oral Complications | — | UNRESOLVED | — |
| Radiation Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| amifostine trihydrate | Drug | — | UNRESOLVED |
| carboplatin | Drug | Carboplatin | ALIAS |
| cisplatin | Drug | Cisplatin | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Histologically confirmed undifferentiated nasopharyngeal cancer (UNPC)
* Locoregionally advanced disease
* T2b, N1 (greater than 3 cm) or N2
* T3, N1 (greater than 3 cm) or N2
* T4, N1 (greater than 3 cm) or N2
* Any T, N3
* No squamous cell histology
* At least 1 unidimensionally measurable target lesion
* At least 20 mm by conventional techniques OR
* At least 10 mm by spiral CT scan
* No evidence of distant metastases
* No signs or symptoms of CNS metastases
PATIENT CHARACTERISTICS:
Age:
* 15 to 70
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 150,000/mm\^3
* Hemoglobin at least 12 g/dL
Hepatic:
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* AST/ALT no greater than 2.5 times ULN
Renal:
* Creatinine clearance at least 70 mL/min
* Calcium normal
Cardiovascular:
* No hypotension or hypertension requiring therapy
* No prior myocardial infraction
* No pre-existing uncontrolled cardiac disease
* No signs of cardiac failure
* No rhythm disturbances requiring medication
Other:
* No sensory neuropathy grade 2 or greater unless due to cranial nerve
* No uncontrolled infections
* No sensitivity to aminothiol compounds
* No other malignancy within the past 5 years except adequately controlled carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study
* Fertile patients must use effective contraception during and for 3 months after study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy
Chemotherapy:
* No prior chemotherapy for UNPC
Endocrine therapy:
* No concurrent hormonal therapy except corticosteroids for antiemetic prophylaxis
Radiotherapy:
* No prior radiotherapy for UNPC
Surgery:
* No prior surgery for UNPC except cervical lymphadenectomy
Other:
* At least 1 month since prior investigational agent
* No other concurrent anticancer drugsReferences
Publications (0)
Data not yet available