Clinical trial · Interventional
Pre-operative Chemotherapy Versus Concurrent Chemoradiotherapy in Locally Advanced Non-small Cell Lung Cancer
A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
NCT01054482CI-TRIAL-00003083unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pre-operative chemotherapy | Drug | — | UNRESOLVED |
| Pre-operative concurrent chemoradiation therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Pre-operative chemotherapy
- description
- Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op \& Post-Op (total 4 cycles)
- interventionNames
- Drug: Pre-operative chemotherapy
- type
- ACTIVE_COMPARATOR
- label
- Pre-operative concurrent chemoradiation therapy
- interventionNames
- Other: Pre-operative concurrent chemoradiation therapy
Primary outcomes (1)
- measure
- To estimate the time to recurrence
- timeFrame
- Every 3 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologic diagnosis of non small-cell lung cancer * Clinical stage IIIA and/or IIIB without pleural effusion * ECOG functional status 0 or 1 * No renal function alteration (GFR \>50%) * No hepatic function alteration (ALT and AST less than 2 times its normal value) * Leucocytes more than 2,000/mcl * Hemoglobin more than 10mg/dL * Platelets more than 100,000/mcl Exclusion Criteria: * Active uncontrolled infection. * Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy. * MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia. * Significant neurological or mental disorder. * Second primary malignancy. * Pregnant or nursing.
References
Publications (0)
Data not yet available
No reference posted for this study.