Status:
UNKNOWN
Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases
Lead Sponsor:
Shanghai Jiao Tong University School of Medicine
Conditions:
Non-small Cell Lung Cancer
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
- Pretreatment with any other cytostatic therapy
- Previous radiotherapy to the chest
- Concurrent treatment with prednisone (or equivalent) except: for the prophylactic medication regimen before treatment, treatment of acute hypersensitivity reactions or chronic treatment (initiated \> 6 months prior to trial entry) at low dose (£ 20 mg methylprednisolone or equivalent)
- Definite contraindications for the use of corticosteroids as premedication
- Treatment within a clinical trial within 30 days prior to trial entry
- Socioeconomic or geographic circumstances that may prohibit proper staging, treatment or follow-up procedures
- Pregnancy, lactation period
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2013
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01187290
Start Date
August 1 2010
End Date
June 1 2013
Last Update
August 24 2010
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