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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00490659 |
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Date of registration:
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21/06/2007 |
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Primary sponsor: |
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Public title:
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Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes
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Scientific title:
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A Phase II Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (-With Weekly Low-Dose Gemcitabine) in the Treatment of Nodes Positive NSCLC Patients |
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Date of first enrolment:
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September 2003 |
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Target sample size:
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13 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00490659 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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Poland
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Contacts
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Name:
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For
patients entering Arm B is also allowed to confirm histopathological diagnosis of
NSCLC intraoperatively during this trial.
- Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or
T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of
American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For
patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained
from intraoperative or post-surgery pathology report.
- Tumor amenable to curative surgical resection.
- Patients with clinically measurable lesions will be enrolled in this study.
Measurability is determined according to RECIST criteria.
• Pathological evaluation is performed after mediastinoscopy or after surgery
- No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular
targeted therapy, or any other type of tumor therapy).
Exclusion Criteria:
- Treatment within the last 30 days with any investigational drug.
- Concurrent administration of any other tumor therapy, including radiotherapy,
cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- Serious concomitant disorders (for example, heart failure, poorly controlled
diabetes) at the investigator’s discretion.
- Presence of an uncontrolled, active infection requiring therapy (at the discretion of
investigator.).
- Stage IIIb or IV.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Drug: cisplatin
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Drug: gemcitabine
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Procedure: chemoradiotherapy
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Procedure: radical surgery
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Primary Outcome(s)
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2-year overall survival
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Secondary Outcome(s)
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Assessment of feasibility of two treatment orders
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Clinical and pathological response rate to neoadjuvant chemotherapy
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Disease free survival
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Toxicity assessment
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Secondary ID(s)
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8191
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B9E-MC-S339
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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