Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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 April 16, 2014