Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head an… (NCT00352118) | Clinical Trial Compass
TerminatedPhase 2
Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Stopped: Low dose radiation treatment was not appropriate for these patients.
United States4 participantsStarted 2006-03
Plain-language summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, 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. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.
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 confirmed squamous cell carcinoma of the head and neck
* Stage IVA or IVB disease
* Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
* Measurable or evaluable disease
* ECOG performance status 0-2
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
* Bilirubin normal
* Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
* AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
* AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
* AP ≤ 5 times ULN AND AST or ALT normal
Exclusion Criteria:
* Salivary gland, sinus, or nasopharyngeal primary disease
* Evidence of distant metastatic disease
* Pregnant or nursing
* Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
* Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
* Peripheral neuropathy ≥ grade 2
* Hearing loss ≥ grade 2
* Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
* Poor nutritional status, in the op…
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
Number of Patients With Feeding Tube Dependency
Timeframe: at 12 months
Trial details
NCT IDNCT00352118
SponsorMasonic Cancer Center, University of Minnesota