- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
-
Seoul, Korea, Republikken, 120-752
- Rekruttering
- Yonsei Cancer Center at Yonsei University Medical Center
-
Ta kontakt med:
- Joo-Hang Kim, MD
- Telefonnummer: 82-2-2228-8131
- E-post: kjhang@yuhs.ac
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
---|
Objective response rate (complete or partial response) as assessed by RECIST criteria
|
Sekundære resultatmål
Resultatmål |
---|
Progresjonsfri overlevelse
|
Total overlevelse
|
Toxicity as assessed by NCI CTCAE v3.0 criteria
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- stadium III plateepitelkarsinom i leppe og munnhule
- stadium III verrucous karsinom i munnhulen
- stadium IV plateepitelkarsinom i leppe og munnhule
- stadium IV verrucous karsinom i munnhulen
- stadium III plateepitelkarsinom i orofarynx
- stadium III lymfepitelom i orofarynx
- stadium IV plateepitelkarsinom i orofarynx
- stadium IV lymfepitheliom i orofarynx
- stadium III plateepitelkarsinom i nasopharynx
- stadium III lymfepitelom i nasofarynx
- stadium IV plateepitelkarsinom i nasopharynx
- stadium IV lymfepitheliom i nasofarynx
- stadium III plateepitelkarsinom i hypopharynx
- stadium IV plateepitelkarsinom i hypopharynx
- tungekreft
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CDR0000582621
- YONSEI-4-2006-021-0
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på docetaksel
-
Tianjin Medical University Cancer Institute and...Rekruttering
-
Zhuhai Beihai Biotech Co., LtdFullførtSolide svulster | Bioekvivalens | DocetaxelIndia
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaFullførtIkke-småcellet lungekreft (NSCLC)Kina
-
Optimal Health ResearchFullførtBrystkreft | Lungekreft | ProstatakreftForente stater
-
Fudan UniversityHar ikke rekruttert ennåAvansert ikke-småcellet lungekreft
-
Seoul National University HospitalClinical Research Center for Solid Tumor, KoreaAvsluttetPlateepitelkarsinom i hode og nakkeKorea, Republikken
-
Hunan Cancer HospitalChia Tai Tianqing Pharmaceutical Group Co., Ltd.; Hunan Provincial People...UkjentIkke-småcellet lungekreftKina
-
Jiangsu HengRui Medicine Co., Ltd.Shanghai Pulmonary Hospital, Shanghai, ChinaAvsluttetIkke plateepitel, ikke småcellet lungeKina
-
University of OxfordUkjent