Clinical trial · Interventional
Phase II Trial of Regimen for Stage III (N2) NSCLC Using Induction Treatment Followed by Resection
A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection
NCT01926483CI-TRIAL-00011816ZTOG-1202unknownPhase 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)
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.
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 Stage IIIA | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemoradiotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Neoadjuvant Treatment
- description
- Neoadjuvant Chemoradiotherapy
- interventionNames
- Other: Neoadjuvant Chemoradiotherapy
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 3 years
Secondary outcomes (3)
- measure
- Adverse events
- timeFrame
- participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years
- description
- observe and record the toxicity profile(including but not limit to mucositis,liver and kidney function,et al.)according NCI-CTCAE(3rd edition) during the neoadjuvant chemoradiation and follow-up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * 18≤Age≤65; * ECOG performance status of 0 or 1; * Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT; * WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal; * Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer; * The patient can understand the research and sign the informed consent. Exclusion Criteria: * Female in pregnancy or lactating;Female of childbearing age without contraception; * With acute infection or other serious underlying disease; * With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent; * Have received other treatment within the last 30 days before enrollment; * With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).
References
Publications (0)
Data not yet available
No reference posted for this study.