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| ID | Type | Description | Link |
|---|---|---|---|
| YONSEI-4-2006-021-0 |
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RATIONALE: Drugs used in chemotherapy, such as docetaxel, S-1, and cisplatin, 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 more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel and S-1 together with radiation therapy and low-dose cisplatin works in treating patients with stage III or stage IV head and neck cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE:
After completion of study therapy, patients are followed periodically for 18 months.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cisplatin | Drug | |||
| docetaxel | Drug | |||
| tegafur-gimeracil-oteracil potassium | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (complete or partial response) as assessed by RECIST criteria |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | ||
| Overall survival | ||
| Toxicity as assessed by NCI CTCAE v3.0 criteria |
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DISEASE CHARACTERISTICS:
Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:
Locally advanced disease (stage III or IV [M0] disease)
At least 1 unidimensionally measurable index lesion
PATIENT CHARACTERISTICS:
ECOG performance status 0-2
ANC ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
Bilirubin ≤ 1.5 times the upper limit of normal (ULN)
Alkaline phosphatase ≤ 3.0 times ULN
AST and ALT ≤ 3.0 times ULN
Creatinine ≤ 1.5 times ULN
No concurrent serious systemic disorder that, in the opinion of investigator, would compromise the patient's ability to complete the study
No serious cardiac condition, including any of the following:
No active infection requiring IV antibiotics, including active tuberculosis or HIV
No other malignancy within the past 5 years except basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix
Able to comply with protocol or study procedures
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Joo-Hang Kim, MD | Yonsei University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yonsei Cancer Center at Yonsei University Medical Center | Recruiting | Seoul | 120-752 | South Korea |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| D014062 | Tongue Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009062 | Mouth Neoplasms |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D014060 | Tongue Diseases |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| D000077143 | Docetaxel |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D013812 | Therapeutics |
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