- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00002852
Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer
A PHASE III STUDY OF ADJUVANT CHEMOTHERAPY AFTER RESECTION FOR PATIENTS WITH T2N0 STAGE I NON-SMALL CELL CARCINOMA OF THE LUNG
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
PRIMARY OBJECTIVES:
I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).
SECONDARY OBJECTIVES:
I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.
II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.
Arm I:Patients receive no further therapy.
Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
Patients are followed every 4 months for 2 years and then every 6 months thereafter.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Kontakter och platser
Studieorter
-
-
Illinois
-
Chicago, Illinois, Förenta staterna, 60606
- Cancer and Leukemia Group B
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Histologically documented non-small cell carcinoma
- Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
- Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
- Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
- No prior chemotherapy or radiation for non-small cell lung cancer
- Performance status of 0 or 1
- Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
- Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
- Granulocytes >= 1,800/ul
- Platelets >= 100,000/ul
- Bilirubin < 1.5 mg/dl
- SGOT (AST) < 2.0 x ULN
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: Arm I (surgery, observation)
Patients receive no further therapy.
|
Genomgå kirurgi
|
Experimentell: Arm II (surgery, chemotherapy)
Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1.
Treatment continues every 3 weeks for 4 courses.
|
Givet IV
Andra namn:
Givet IV
Andra namn:
Genomgå kirurgi
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall survival (OS)
Tidsram: Up to 2.4 years
|
OS curves will be calculated using the Kaplan-Meier life-table method.
Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.
|
Up to 2.4 years
|
Failure-free survival
Tidsram: Time between randomization and disease relapse or death, assessed up to 2.4 years
|
Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.
|
Time between randomization and disease relapse or death, assessed up to 2.4 years
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Toxicity as assessed by Common Toxicity Criteria version 2.0
Tidsram: Up to 1 year after completion of treatment
|
Up to 1 year after completion of treatment
|
|
Pattern of disease recurrence.
Tidsram: Up to 2 years
|
The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.
|
Up to 2 years
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Gary Strauss, Cancer and Leukemia Group B
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
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
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Neoplasmer efter histologisk typ
- Neoplasmer
- Lungsjukdomar
- Neoplasmer efter plats
- Adenocarcinom
- Carcinom
- Neoplasmer, körtel och epitel
- Neoplasmer i andningsvägarna
- Thoracic neoplasmer
- Karcinom, bronkogent
- Bronkiella neoplasmer
- Lungneoplasmer
- Karcinom, icke-småcellig lunga
- Adenocarcinom i lungan
- Adenokarcinom, bronkiolo-alveolär
- Molekylära mekanismer för farmakologisk verkan
- Antineoplastiska medel
- Tubulin modulatorer
- Antimitotiska medel
- Mitosmodulatorer
- Antineoplastiska medel, fytogena
- Karboplatin
- Paklitaxel
Andra studie-ID-nummer
- NCI-2012-02967
- U10CA031946 (U.S.S. NIH-anslag/kontrakt)
- CALGB-9633
- CDR0000065095
- CLB-C9633
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 .
Kliniska prövningar på Skivepitelcancer lungcancer
-
Medtronic - MITGAvslutadEsophageal Squamous Cell Neoplasia (ESCN)Kina
-
Assistance Publique - Hôpitaux de ParisRekryteringHistiocytos | Histiocytos, Langerhans-Cell | Histiocytos LungFrankrike
-
Fudan UniversityAktiv, inte rekryterandeOligorecurrent och Oligometastatic Esophageal Squamous Cell CarcinomaKina
-
Fondazione Policlinico Universitario Agostino Gemelli...RekryteringKonjunktivalt melanom | Porocarcinom | Okulär yta Squamous Neoplasia | Merkelcellscancer, ospecificerat | Okulärt talgkarcinom | Okulär basalcellscancerItalien
-
National Cancer Institute (NCI)Aktiv, inte rekryterandeMalign fast neoplasma | Nasofaryngealt karcinom | Adenoid cystiskt karcinom | Övergångscellkarcinom | Kolangiokarcinom | Intrahepatisk kolangiokarcinom | Chordom | Gestationell trofoblastisk tumör | Pseudomyxoma Peritonei | Adenokarcinom i livmoderhalsen | Vaginalt adenokarcinom | Vaginalt skivepitelcancer, ej... och andra villkorFörenta staterna, Guam
-
SpeciCareUniversity of Washington; Georgia Institute of Technology; Predictive Oncology och andra samarbetspartnersRekryteringMelanom | Sarkom | Njurcellscancer | Bröstcancer | Hepatocellulärt karcinom | Övergångscellkarcinom | Glioblastoma Multiforme | Kolangiokarcinom | Småcellig lungcancer | Oligodendrogliom | Cancer i huvud och hals | Cancer i levern | Cancer i bukspottkörteln | Cancer i hjärnan och nervsystemet | Binjurecancer | Cancer i magen | Cancer i livmoderhalsen och andra villkorFörenta staterna
Kliniska prövningar på paklitaxel
-
Nanfang Hospital of Southern Medical UniversityRekrytering
-
University of Texas Southwestern Medical CenterCelgeneAvslutadSTEG IIIA/B NSCLC / Ooperabel lungcancerFörenta staterna
-
Junling LiOkändSmåcellig lungcancer i omfattande skedeKina
-
Cook Group IncorporatedAvslutadPerifer arteriell sjukdom (PAD)Tyskland, Nya Zeeland
-
M.D. Anderson Cancer CenterCelgene CorporationAvslutadMelanom | LevermetastaserFörenta staterna
-
Second Affiliated Hospital, School of Medicine,...Sun Yat-sen University; Peking University International Hospital; Zhejiang...Har inte rekryterat ännuHER2-positiv bröstcancer | HjärnmetastaserKina
-
Rabih A. ChaerAvslutad
-
Qilu Hospital of Shandong UniversityRekryteringAvancerat gastriskt eller gastroesofagealt adenokarcinomKina
-
Fujian Cancer HospitalHar inte rekryterat ännuAvancerad solid tumör
-
Tang-Du HospitalRekryteringThymom och thymuskarcinomKina