Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232206
Status:
TERMINATED
Last Update Posted:
2011-05-18
First Post:
2005-09-30
Brief Title:
Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
Official Title:
A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC
Status:
TERMINATED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
study terminated due to slow accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery neoadjuvant for early stage non-small cell lung cancer NSCLC Secondary objectives of this study include assessment of radiographic response rate by computed tomography CT scanning overall survival time to progression rate of complete surgical removal and adverse reactions In addition this study will test whether positron emission tomography PET imaging can predict a tumor response Patients who have a response to chemotherapy may receive 2 additional cycles after recovering from surgery
Detailed Description:
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IIT 12207 | None | None | None |