Preoperative Chemoradiotherapy vs. Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases (Stage IIIA, N2): A Randomized Prospective Phase II Trial

Shanghai Jiao Tong University School of Medicine0 sites80 target enrollmentAugust 2010

ConditionsNon-small Cell Lung Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Non-small Cell Lung Cancer
Sponsor: Shanghai Jiao Tong University School of Medicine
Enrollment: 80
Primary Endpoint: Event-free survival
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The main objective of this trial is to compare feasibility and efficacy of sequential neoadjuvant chemoradiotherapy with 44Gy concomitant boost to neoadjuvant chemotherapy alone. Secondary objectives are to assess the value of position emission tomography (PET）in predicting pathological response and event-free survival（EFS）in stage IIIA non-small cell lung cancer (NSCLC). Further to compare the amount of serum DNA in patients with stage IIIa NSCLC before, during and after chemotherapy, before and after radiotherapy (in arm A) and during follow-up in patients randomized into the trial and to correlate the Deoxyribonucleic acid (DNA) variation with tumor response, remission duration and overall survival.

Registry

clinicaltrials.gov

Start Date

August 2010

End Date

June 2013

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai Jiao Tong University School of Medicine

Eligibility Criteria

Inclusion Criteria

•Histologically proven NSCLC with nodal metastases: T1-3N2M0
•Performance status 0-1
•Patient medically fit enough for protocol therapy, including operability
•Age 18-75
•Written informed consent
•No previous chemo- or radiotherapy

Exclusion Criteria

•Patients with prior or concomitant malignancies Allowed are: non-melanomatous skin cancer, adequately treated in situ cervical cancer or any other neoplastic diseases with disease-free interval ³ 5 years.
•Presence or history of any distant metastasis
•Unstable cardiac disease requiring treatment, congestive heart failure or angina pectoris even if medically controlled, significant arrhythmia, or prior history of myocardial infarction in the last 3 months
•History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
•Active uncontrolled infection
•Uncontrolled diabetes mellitus
•Gastric ulcers
•Preexisting peripheral neuropathy (\> grade 1)
•Other serious underlying medical condition which could impair the ability of the patient to participate in the trial
•Concurrent treatment with other experimental drugs