Randomized Amifostine For SCCHN (NCT00095927) | Clinical Trial Compass
CompletedPhase 2
Randomized Amifostine For SCCHN
United States58 participantsStarted 2003-05
Plain-language summary
This research study is studying a drug called Amifostine as a treatment for squamous cell carcinoma in the head and/or neck area.
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
* Histologically or cytologically proven squamous cell carcinoma of the head and neck. Biopsy is preferred unless medically contraindicated.
* Primary tumor sites eligible: oral cavity, oropharynx, hypopharynx or larynx. Tumors of the nasal and paranasal cavities will also be included. Unknown primary SCC in the neck will also be eligible.
* Stage 2, 3 or 4 disease without evidence of distant metastases verified by chest X-Ray, abdominal ultrasound or CT (in case of liver function test abnormalities); bone scan in case of local symptoms.
* At least one uni- or bidimensionally measurable lesion at the start of all therapy (induction therapy ag well as chemoradiation).
* No previous head and neck radiotherapy and no previous curative surgery for SCCHN (other than biopsy) are allowed at time of study entry.
* Age ≥ 18 years.
* WHO performance status of 0 or 1 (section 13, Appendix I)
* No active alcohol addiction (as assessed by medical caregiver).
* Life expectancy ≥ 12 weeks.
* Signed informed consent prior to beginning protocol specific procedures.
* Adequate bone marrow, hepatic and renal functions as evidenced by the following:
* Hematology:
* neutrophil count ≥ 2.0 x 10 9/1.
* platelet count ≥ 100 x 10 9/1.
* hemoglobin ≥ 10 g/dl.
* Hepatic function:
* total bilinthin WNL.
* ASAT (SGOT) and ALAT (SGPT) ≤ 2.5 x 1JLN.
* alkaline phosphatase ≤ 5 x ULN.
* patients with ASAT or ALAT \> 1.5 x ULN associated with alkaline pho…
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
Rate of local/regional control (LRC) 1 year after beginning treatment
Timeframe: One year after beginning of treatment
2
Proportion of patients with grade 2 or 3 chronic xerostomia at 3, 6 months
Timeframe: 3, 6 Months
3
Proportion of patients with grade 3 and 4 mucositis as assessed by RTOG criteria once weekly during and after completion of radiotherapy
Timeframe: End of Radiotherapy
4
Median duration of dependence on percutaneous endoscopic gastrectomy (PEG) for adequate nutrition at 8, 12, 24, and 52 weeks after completion of study treatment