Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases
This study is not yet open for participant recruitment.
Verified August 2010 by Shanghai Jiao Tong University School of Medicine
Sponsor:
Shanghai Jiao Tong University School of Medicine
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01187290
First received: August 19, 2010
Last updated: August 23, 2010
Last verified: August 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Non-small Cell Lung Cancer |
Radiation: neoadjuvant chemoradiotherapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Shanghai Jiao Tong University School of Medicine:
Primary Outcome Measures:
- Event-free survival [ Time Frame: five years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Operability [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: No ]
- Postoperative 30-day mortality [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
- Toxicity [ Time Frame: 30 days after treatment ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 80 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 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
|
Radiation: neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
|
|
Experimental: 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
|
Radiation: neoadjuvant chemoradiotherapy
Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01187290
Contacts
| Contact: Luo qingquan, M.D | 86-21-62821990 | liziming1980@yahoo.com.cn |
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
| Study Chair: | luo qingquan, M.D. | Shanghai Chest Hospital |
More Information
No publications provided
| Responsible Party: | Luo qinquan, shanghai chest hospital |
| ClinicalTrials.gov Identifier: | NCT01187290 History of Changes |
| Other Study ID Numbers: | chest1001 |
| Study First Received: | August 19, 2010 |
| Last Updated: | August 23, 2010 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Shanghai Jiao Tong University School of Medicine:
|
Preoperative chemoradiotherapy stage IIIA, N2 |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Neoplasm Metastasis Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms |
Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Neoplastic Processes Pathologic Processes |
ClinicalTrials.gov processed this record on October 17, 2012
