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

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
neoadjuvant chemoradiotherapy
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Preoperative chemoradiotherapy, stage IIIA, N2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    neoadjuvant chemotherapy

    neoadjuvant chemoradiotherapy

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Event-free survival

    Secondary Outcome Measures

    Operability
    Postoperative 30-day mortality
    Toxicity

    Full Information

    First Posted
    August 19, 2010
    Last Updated
    August 23, 2010
    Sponsor
    Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01187290
    Brief Title
    Preoperative Chemoradiotherapy Versus Chemotherapy Alone in Nonsmall Cell Lung Cancer (NSCLC) Patients With Mediastinal Lymph Node Metastases
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2010
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2010 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    June 2013 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-small Cell Lung Cancer
    Keywords
    Preoperative chemoradiotherapy, stage IIIA, N2

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    neoadjuvant chemotherapy
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    neoadjuvant chemoradiotherapy
    Arm Type
    Experimental
    Arm Description
    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
    Intervention Type
    Radiation
    Intervention Name(s)
    neoadjuvant chemoradiotherapy
    Intervention Description
    Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
    Primary Outcome Measure Information:
    Title
    Event-free survival
    Time Frame
    five years
    Secondary Outcome Measure Information:
    Title
    Operability
    Time Frame
    within the first 30 days (plus or minus 3 days) after surgery
    Title
    Postoperative 30-day mortality
    Time Frame
    30 days after treatment
    Title
    Toxicity
    Time Frame
    30 days after treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    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 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Luo qingquan, M.D
    Phone
    86-21-62821990
    Email
    liziming1980@yahoo.com.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    luo qingquan, M.D.
    Organizational Affiliation
    Shanghai Chest Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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

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