- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00232206
Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer
A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US. Surgery is the primary most successful treatment for early stage patients. However, even lung cancers caught at an early stage (stage IB through selected IIIA) have 5 year survivals after surgery at a rate of only 10-60%. Postoperative platinum based chemotherapy offers a 4-15% survival benefit, depending on stage in fit patients after complete surgical removal of early stage disease. Preoperative platinum based chemotherapy has been shown in small randomized trials to benefit patients with stage IIIA, N2 positive disease, but is not standard of care in earlier stage disease, such as the population in this study.
The combination of cisplatin and docetaxel is approved in the US for front line therapy of stage IV NSCLC based on randomized clinical data showing efficacy and manageable toxicity. Given the efficacy and tolerance of this combination in the metastatic setting, this regimen is an obvious choice for study in the neoadjuvant setting.
PET imaging is approved in the US for determining size, site and spread of lung cancer (staging) and has been shown to reduce unnecessary surgery when used as part of preoperative evaluation. Because NSCLC is not 100% responsive to chemotherapy and CT scans may not show a change in tumor size until after several cycles of chemotherapy, PET imaging might be an effective way to provide an earlier and more reliable estimate of response.
Preoperative chemotherapy will be given for a total of two cycles 21 days apart if any adverse events have resolved and there is no evidence of disease progression. Patients will undergo CT chest through liver and PET scans for restaging following the second cycle and will then be scheduled for surgery 3-6 weeks after the second cycle of chemotherapy. Patients who have responded according to CT and/or PET imaging, or surgical pathology will go on to receive an additional two cycles of chemotherapy with docetaxel and cisplatin once the patient has recovered from surgery.
Studietype
Registrering (Forventet)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Oregon
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Portland, Oregon, Forente stater, 97213
- Providence Portland Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC appropriate for surgery
- Medically fit for resection by lobectomy or pneumonectomy
- T1-2N1 disease by CT must have negative N2/N3 nodes by PET
- T3N1 disease must have pathologically negative N2/N3 nodes
- Measurable disease
- Patients must not be receiving other investigational therapy
- Prior surgery for NSCLC okay if resected > or = 5 years prior
- No prior chemotherapy or radiation for NSCLC
- No uncontrolled medical problems
- No factors that would preclude obtaining informed consent
- Age 18 or greater
- Performance status (PS) 0-1
- Peripheral neuropathy must be < grade 1
- Acceptable hematologic and chemistry parameters
- Renal: creatinine clearance (calculated) > 50 cc/min
Exclusion Criteria:
- History of severe hypersensitivity to docetaxel or like drugs
- Pregnant or nursing women
- Prior chemotherapy or radiation for NSCLC
- Symptomatic superior sulcus tumors
- Prior malignancy except for treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer or cancer from which the patient has been disease free for greater than three years
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Hva måler studien?
Primære resultatmål
Resultatmål |
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Primary objective: To assess the pathologic complete and partial response rate to neoadjuvant treatment with two cycles of cisplatin and docetaxel chemotherapy prior to resection of early stage NSCLC
|
Sekundære resultatmål
Resultatmål |
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Secondary objectives: Assessment of radiographic response rate by CT scanning, overall survival, time to progression, rate of complete surgical resection and toxicity
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Evaluation of the predictive power of PET to define pathologic response
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Brendan Curti, MD, Director, Lung Research
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført
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
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Docetaxel
Andre studie-ID-numre
- PPMC-EACRI-IRB-05-032
- IIT #12207
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. .
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