- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00193427
Preoperative Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Phase II Trial of Preoperative (Neo-adjuvant) Therapy in Patients With Stages IB, II, IIIA, and Selected IIIB Patients With Non-Small Cell Lung Cancer
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Upon determination of eligibility, patients will receive:
Pre-operative
- Docetaxel
- Gemcitabine Post-operative
- Docetaxel
- Carboplatin
- Radiation Therapy
Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Tennessee
-
Nashville, Tennessee, Förenta staterna, 37023
- Tennessee Oncology, PLLC
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
To be included in this study, you must meet the following criteria:
- Histologically confirmed non-small cell lung cancer
- Must be operable candidate
- Clinical stage IB, II, and select III non-small cell lung cancer are eligible
- Measurable or evaluable disease
- Able to perform activities of daily living with minimal assistance
- Must be > 18 years of age
- Adequate bone marrow, liver or kidney
- No previous chemotherapy or radiation therapy for non-small cell lung cancer
- Moderate to severe peripheral neuropathy
- Understand the nature of this study and give written informed consent.
Exclusion Criteria:
You cannot participate in this study if any of the following apply to you:
- Stage IV disease
- History of prior malignancy within five years
- Women who are pregnant or breast-feeding
Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Intervention
Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles.
Patients were restaged after treatment and resected 3-6 weeks later.
If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
|
30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles
Andra namn:
1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles
Andra namn:
AUC = 1.5 weekly x 7
Andra namn:
To 63 Gy
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Pathologic Complete Response Rate
Tidsram: 18 months
|
A pathological complete response (pCR) was defined as having no residual cancer at the primary site or in regional lymph nodes on pathologic review.
|
18 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Progression Free Survival (PFS)
Tidsram: 19 months
|
Progression-free survival was calculated as the elapsed time between the date of study registration and the date of recurrence or death from any cause.
|
19 months
|
Overall Response Rate (ORR)
Tidsram: 18 months
|
Overall response rate is the percentage of patients with complete response or partial response per RECIST v.1 Criteria.
Complete response (CR) = Disappearance of all target lesions, disappearance of all nontarget lesions for at least 4 weeks.
Partial Response (PR) = At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of longest diameters.
|
18 months
|
Overall Survival (OS)
Tidsram: 18 months
|
Overall survival was calculated as the elapsed time bewteen date of study registration and the date of death.
|
18 months
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Lungneoplasmer
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Anti-infektionsmedel
- Antivirala medel
- Enzyminhibitorer
- Antimetaboliter, antineoplastiska
- Antimetaboliter
- Antineoplastiska medel
- Immunsuppressiva medel
- Immunologiska faktorer
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Gemcitabin
- Docetaxel
- Karboplatin
Andra studie-ID-nummer
- SCRI LUN 76
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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