Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00526643
Status:
TERMINATED
Last Update Posted:
2017-03-28
First Post:
2007-09-06
Brief Title:
CAPPA-2 Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients
Sponsor:
National Cancer Institute Naples
Organization:
National Cancer Institute Naples
Study Overview
Official Title:
Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition Performance Status 2
Status:
TERMINATED
Status Verified Date:
2017-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
scarce enrolment and presentation of positive results of similar study in June 2012
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPPA-2
Brief Summary:
The primary objective of this study is to evaluate the impact on overall survival OS of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition PS 2 not previously treated
Detailed Description:
Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer NSCLC regardless of treatment received Chemotherapy is recommended for advanced NSCLC patients in good clinical condition but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition performance status 2 This category of patients represents about 20 of all patients at initial diagnosis of NSCLC and remains a treatment challenge for the clinician There have been very few studies that have evaluated the impact of chemotherapy for this group of patients and there is no established standard therapy Studies evaluating single agent and combination two-agent chemotherapy regimens impact on survival and improving symptoms are needed
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 |
|---|---|---|---|
| 2005-005631-97 | EUDRACT_NUMBER | None | None |