Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally … (NCT00025298) | Clinical Trial Compass
TerminatedPhase 2
Chemotherapy Plus Radiation Therapy With or Without Amifostine in Treating Patients With Locally Advanced Cancer of the Nasopharynx
Stopped: low accrual
Belgium, France, Italy5 participantsStarted 2001-07
Plain-language summary
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.
Who can participate
Age range
15 Years – 70 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 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, fa…
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.
Trial details
NCT IDNCT00025298
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC