Status:
TERMINATED
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Non-Small Cell Lung Cancer
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy i...
Detailed Description
This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSC...
Eligibility Criteria
Inclusion
- histologic or cytologic diagnosis of NSCLC
- Presence of clinical Stage IIA,IIB or IIA disease
- tumor amenable to curative surgical resection
- Patients with clinically measurable lesions will be enrolled in this study.
- No prior tumor therapy
- Performance status of 0-1 on ECOG Scale
- Patients compliance and geographic proximity that allow adequate follow-up.
- Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.
Exclusion
- Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
- Treatment within the last 30 days with any investigational drug.
- Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
- Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
- pregnancy/breast feeding
- Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
- poorly controlled diabetes mellitus
- Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
- History of significant neurological or mental disorder, including seizures or dementia.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00291850
Start Date
June 1 2005
Last Update
May 1 2012
Active Locations (5)
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1
AKH, Universitätsklinik für Innere Medizin 1
Vienna, Austria, 1090
2
Somogy Country Pulmo and Cardio Hospital,
Mosdós, Hungary
3
Markusovszky Hospital
Szombathely, Hungary
4
M. Sklodowska-Curie Memorial Dep. Of Lung and Thoracic Tumours,
Warsaw, Poland, 02-781