Phase 2
Completed N=68
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
Head and Neck Cancer · Oral Complications of Radiation Therapy · Radiation Toxicity
Source: ClinicalTrials.gov NCT00057785 ↗
Enrolled (actual)
68
Serious AEs
80.9%
Results posted
Oct 2014
Primary outcomePrimary: Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered — 9 participants
Summary
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may cause less damage to normal tissue, prevent or lessen mouth dryness, and may help patients live more comfortably. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of specialized radiation therapy techniques with or without chemotherapy in reducing mouth dryness in patients who have nasopharyngeal cancer.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered |
9 | — |
| SECONDARY Rate of Xerostomia at 1 Year (Grade ≥ 2) |
— | — |
| SECONDARY Rate of Locoregional Control at 2 Years |
— | — |
| SECONDARY Whole Mouth Saliva Output Relative to Pretreatment Measurements |
— | — |
| SECONDARY Other Acute and Late Toxicities |
— | — |
| SECONDARY Chemotherapy Compliance |
— | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed stage I-IVB squamous cell carcinoma of the nasopharynx
- WHO I-III
- No stage IVC disease
- No evidence of distant metastasis
- Measurable or evaluable disease
- Must have been treated with primary radiotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- Zubrod 0-1
Life expectancy
- Not specified
Hematopoietic
- White blood cell count (WBC) at least 4,000/mm^3
- Platelet count at least 100,000/mm^3
Hepatic
- Not specified
Renal
- Creatinine no greater than 1.6 mg/dL
- Creatinine clearance at least 60 mL/min
Other
- Not pregnant (If stage T2b or greater or node-positive disease)
- Negative pregnancy test (If stage T2b or greater or node-positive disease)
- No other prior head and neck cancer
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- No active untreated infection
- No other major medical or psychiatric illness that would preclude study entry
- Nutritional and general physical condition compatible with radiotherapy NOTE: *If stage T2b or greater or node-positive disease
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- More than 6 months since prior chemotherapy
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
- More than 6 months since prior radiotherapy for head and neck cancer
Surgery
- No prior head and neck surgery to the primary tumor or lymph nodes except incisional or excisional biopsies
Other
- No other concurrent experimental therapy for cancer
- No amifostine or pilocarpine during or for 3 months after radiotherapy
Data sourced from ClinicalTrials.gov (NCT00057785). 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.