Phase II Trial of Dose-Dense Paclitaxel and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Stage II and IIIA Non-Small Cell Lung Cancer - not available

• Conditions: Operable Stage II and IIIA Non-Small Cell Lung Cancer; MedDRA version: 7.0Level: NSLCClassification code 10061873

• Registration Number: EUCTR2004-000804-41-HU
• Lead Sponsor: CECOG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-18
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

[1]Histologic or cytologic diagnosis of NSCLC (any subtype).
[2]Presence of clinical Stage IIA, IIB or IIIA (T3 N1) disease, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997)
[3]Tumor amenable to curative surgical resection.
[4]Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to criteria defined in 3.8.12.
[5]No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular target therapy, or any other type of tumor therapy).
[6]Performance status of 0-1 on ECOG scale
[9]Adequate organ function including the following:
Adequate bone marrow reserve: White blood cells (WBC) ³3.0 ´ 109/L, absolute neutrophil (segmented and bands) count (ANC) ³1.5 ´ 109/L, platelets ³100 ´ 109/L and hemoglobin ³10 g/dL.
Hepatic: bilirubin £1.0 x upper limit of normal (ULN), ALT and AST £2.5 x ULN, alkaline phosphatase £1.0 x ULN, Calcium £1.2 times the ULN
Renal: creatinine £1.5 x ULN and calculated/measured creatinine clearance >50 ml/min (Cockcroft-Gault formula, See Protocol Attachment 3).
[11]Males and females, age ³18 to 65 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

[13]Presence of clinical Stage IIIA (T3 N2) disease, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997)
[14]Treatment within the last 30 days with any investigational drug.
[15]Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
[16]Active infection that in the opinion of the investigator would compromise the patient’s ability to tolerate therapy.
[17]Pregnancy.
[18]Breast feeding.
[19]Serious concomitant disorders that would compromise the safety of the patient or compromise the patient’s ability to complete the study, at the discretion of the investigator.
[20]Poorly controlled diabetes mellitus.
[21]Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
[22]History of significant neurological or mental disorder, including seizures or dementia

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: clinical response rate (cORR) ;Secondary Objective: ·To evaluate the safety of neo-adjuvant chemotherapy with PC:<br>-To characterize the toxicity of PC, including febrile neutropenia.<br>-To evaluate peri- and post-operative mortality.<br>·To determine the pathological complete response rate (pCR).<br>·To determine the complete tumor resection rate <br>·To evaluate proportion of cycle 2 and all cycles chemotherapy given with planned dose-on-time and proportion of patients receiving planned dose-on-time in cycle 2 and over all cycles<br>·To evaluate the following time-to-event efficacy variables:<br>-Disease Free Survival.<br>-Overall Survival <br>·To evaluate Quality of Life (EORTC QLQ – C30 and QLQ- LC13)<br>;Primary end point(s): clinical response rate (cORR)