Clinical trial · Interventional
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA Non-Small Cell Lung Cancer
NCT00291850CI-TRIAL-00006821terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): no patient recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel, Cisplatin, Pegfilgrastim | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (10)
- measure
- >To evaluate the safety of neo-adjuvant chemotherapy with PC
- measure
- - to characterize the toxicity of PC, include febrile neutropenia.
- measure
- - to evaluate peri- and post-operative mortality
- measure
- > to determine the pathological complete response rate
- measure
- > to determine the complete tumor resection rate
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.