Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed N… (NCT00274937) | Clinical Trial Compass
CompletedPhase 3
Radiation Therapy, Amifostine, and Chemotherapy in Treating Young Patients With Newly Diagnosed Nasopharyngeal Cancer
United States, Australia, Canada111 participantsStarted 2006-02-20
Plain-language summary
This phase III trial is studying how well radiation therapy, amifostine, and chemotherapy work in treating young patients with newly diagnosed nasopharyngeal cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as amifostine, may protect normal cells from the side effects of radiation therapy. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with amifostine and chemotherapy may kill more tumor cells.
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.
Inclusion Criteria:
* Histological diagnosis of nasopharyngeal carcinoma WHO type II or III
* Stage I-IV disease
* Newly diagnosed disease
* Performance status
* Patients ≤ 16 years of age: Lansky 60-100%
* Patients \> 16 years of age: Karnofsky 60-100%
* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min
* Creatinine based on age/gender as follows:
* No greater than 0.4 mg/dL (for patients 1 month to \< 6 months of age)
* No greater than 0.5 mg/dL (for patients 6 months to \< 1 year of age)
* No greater than 0.6 mg/dL (for patients 1-2 years of age)
* No greater than 0.8 mg/dL (for patients \< 6 years of age)
* No greater than 1.0mg/dL (for patients 6 to \< 10 years of age)
* No greater than 1.2 mg/dL (for patients 10 to \< 13 years of age)
* No greater than 1.4 mg/dL (for female patients 13 to ≥ 16 years of age)
* No greater than 1.5 mg/dL (for male patients 13 to \< 16 years of age)
* No greater than 1.7 mg/dL (for male patients ≥ 16 years of age)
* Bilirubin ≤ 1.5 times upper limit of normal (ULN) for age
* AST or ALT \< 2.5 times ULN for age
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior chemotherapy or radiotherapy to the nasopharynx or neck for the treatment of nasopharyngeal carcinoma
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.