Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV … (NCT00707473) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Docetaxel, Cisplatin and Fluorouracil in Treating Patients With Previously Untreated Stage II-IV Nasal Cavity and Paranasal Sinus Cancer
United States31 participantsStarted 2008-06-16
Plain-language summary
This phase II trial studies how well docetaxel, cisplatin and fluorouracil work in treating patients with previously untreated stage II-IV nasal cavity and/or paranasal sinus cancer. 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, by stopping them from dividing, or by stopping them from spreading.
Who can participate
Age range
17 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:
* Patients must have a confirmed (by a MD Anderson Cancer Center \[MDACC\] pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses.
* Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0. Measurable disease is required with the following criteria: Measurable lesions can be accurately measured, with at least one diameter \>= 1.0 cm by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements \< 2.0 cm; or \< 1.0 cm with spiral CT).
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1.
* Absolute peripheral granulocyte count (AGC) of \>= 1500 cells/mm\^3.
* Platelet count of \>= 100,000 cells/mm\^3.
* Total bilirubin =\< upper limit of normal (ULN). If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria.
* Alkaline phosphatase =\< 2 x ULN. If in the judgment of …
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
Clinical/radiographic complete rate after induction chemotherapy with docetaxel, cisplatin, and fluorouracil