Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopha… (NCT00057785) | Clinical Trial Compass
CompletedPhase 2
Radiation Therapy With or Without Chemotherapy in Reducing Mouth Dryness in Patients With Nasopharyngeal Cancer
United States68 participantsStarted 2003-02
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 excision…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Protocol Compliance of Intensity-modulated Radiotherapy Treatment Delivered
Timeframe: From start of treatment to end of treatment