Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC
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 in this patient population.
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 NSCLC. Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines. Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle. All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.
Interventions
DRUGPaclitaxel, Cisplatin, Pegfilgrastim
Sponsors
Central European Cooperative Oncology Group
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the evaluation of the clinical response rate of neo-adjuvant chemotherapy with dose-dense therapy of paclitaxel and cisplatin(PC) with peg-filgrastim in patients with operable NSCLC | — |
Secondary
| Measure | Time frame |
|---|---|
| - to characterize the toxicity of PC, include febrile neutropenia. | — |
| - to evaluate peri- and post-operative mortality | — |
| > to determine the pathological complete response rate | — |
| > to determine the complete tumor resection rate | — |
| >To evaluate the safety of neo-adjuvant chemotherapy with PC | — |
| > To evaluate the following time-to-event efficacy variables: | — |
| - disease free survival | — |
| - overall survival | — |
| > to evaluate Quality of life (EORTC QLQ-C30 and QLQ-LC13) | — |
| > 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. | — |
Countries
Austria, Hungary, Poland
Outcome results
None listed