Phase 2
Completed N=25
High-Dose Radiation Therapy Plus Chemotherapy in Treating Patients With Advanced Nose or Throat Cancer
Source: ClinicalTrials.gov NCT00052429 ↗Enrolled (actual)
25
Serious AEs
76.0%
Results posted
Feb 2016
Primary outcomePrimary: Survival Rate of Patients — 33 months
Summary
RATIONALE: Radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining high-dose radiation with chemotherapy may kill more tumor cells.
PURPOSE: Phase I/II trial to study the effectiveness of combining high-dose radiation therapy with chemotherapy in treating patients who have newly diagnosed stage II, stage III, or stage IV nasopharyngeal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Survival Rate of Patients |
33 | — |
| PRIMARY Local Control of Participants |
91; 91; 91; 89 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed nasopharyngeal cancer
- Stage II-IVB
- Newly diagnosed
- No distant metastases
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- WBC at least 3,000/mm^3
- Granulocyte count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
- Hemoglobin at least 8 g/dL
Hepatic
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- Alkaline phosphatase no greater than 2.5 times ULN
- AST no greater than 2.5 times ULN
Renal
- Creatinine no greater than 1.5 mg/dL
- Creatinine clearance at least 60 mL/min
- Calcium no greater than 11.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Medically able to tolerate a definitive course of radiotherapy and the necessary immobilization
- No other active malignancy within the past 3 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- No prior chemotherapy for this diagnosis
- More than 3 years since other prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- No prior radiotherapy for this diagnosis
- More than 3 years since other prior radiotherapy
- No prior radiotherapy to the head and neck region
Surgery
- Not specified
Data sourced from ClinicalTrials.gov (NCT00052429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.