Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases
NCT ID: NCT01187290
Last Updated: 2010-08-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
80 participants
INTERVENTIONAL
2010-08-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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neoadjuvant chemotherapy
Chemotherapy Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
neoadjuvant chemoradiotherapy
Docetaxel 75 mg/m2 1 hour iv infusion d1 Cisplatin 100 mg/m2 1 hour iv infusion d1 Schedule: 3 cycles repeated every 21 days
neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
Interventions
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neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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shanghai chest hospital
Principal Investigators
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luo qingquan, M.D.
Role: STUDY_CHAIR
Shanghai Chest Hospital
Central Contacts
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Other Identifiers
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chest1001
Identifier Type: -
Identifier Source: org_study_id
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