- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00625937
Docetaxel and S-1 Followed By Radiation Therapy and Low-Dose Cisplatin in Treating Patients With Stage III or Stage IV Head and Neck Cancer
A Phase ll Trial of Induction Docetaxel and S-1 Followed by Concomitant Radiotherapy With Low-dose Daily Cisplatin in Locally Advanced Head and Neck Cancer
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
OBJECTIVES:
Primary
- To assess the response rate in patients with stage III or IV head and neck cancer treated with induction therapy comprising docetaxel and S-1 followed by radiotherapy and low-dose cisplatin.
Secondary
- To assess the effect of this regimen on survival and locoregional and systemic control rates in these patients.
OUTLINE:
- Induction chemotherapy: Patients receive oral S-1 twice daily on days 1-14 and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
- Chemoradiotherapy: Patients receive low-dose cisplatin IV once daily and undergo radiotherapy 5 days a week for 7 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study therapy, patients are followed periodically for 18 months.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Seoul, Korea, Republiken av, 120-752
- Rekrytering
- Yonsei Cancer Center at Yonsei University Medical Center
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Kontakt:
- Joo-Hang Kim, MD
- Telefonnummer: 82-2-2228-8131
- E-post: kjhang@yuhs.ac
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
DISEASE CHARACTERISTICS:
Pathologically confirmed head and neck cancer arising from the oral cavity, oropharynx, hypopharynx, or nasopharynx, including any of the following subtypes:
- Squamous cell carcinoma
- Poorly differentiated carcinoma
- Lymphoepithelioma
- 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:
- Myocardial infarction within the past 6 months
- Angina
- NYHA class III-IV heart disease
- 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:
- No prior radiotherapy or chemotherapy
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
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Objective response rate (complete or partial response) as assessed by RECIST criteria
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Sekundära resultatmått
Resultatmått |
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Progressionsfri överlevnad
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Total överlevnad
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Toxicity as assessed by NCI CTCAE v3.0 criteria
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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
- stadium III skivepitelcancer i läppen och munhålan
- stadium III verrucous karcinom i munhålan
- stadium IV skivepitelcancer i läppen och munhålan
- stadium IV verrucous karcinom i munhålan
- stadium III skivepitelcancer i orofarynx
- stadium III lymfepitelom i orofarynx
- stadium IV skivepitelcancer i orofarynx
- stadium IV lymfepitelom i orofarynx
- stadium III skivepitelcancer i nasofarynx
- stadium III lymfepitelom i nasofarynx
- stadium IV skivepitelcancer i nasofarynx
- stadium IV lymfepitelom i nasofarynx
- stadium III skivepitelcancer i hypofarynx
- stadium IV skivepitelcancer i hypofarynx
- tungcancer
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CDR0000582621
- YONSEI-4-2006-021-0
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