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S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00014196
Recruitment Status : Terminated (This study was closed early due to poor accrual.)
First Posted : January 27, 2003
Last Update Posted : February 15, 2013
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: cisplatin Drug: docetaxel Radiation: radiation therapy Phase 2

Detailed Description:


  • Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
  • Determine the response rate in these patients when treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.

At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer
Study Start Date : March 2001
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
Experimental: chemo/RT followed by consolidation chemo
cisplatin docetaxel radiation therapy
Drug: cisplatin
Drug: docetaxel
Radiation: radiation therapy

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IIIB non-small cell lung cancer

    • Adenocarcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
  • Pathologically or radiographically documented positive N3 nodes

    • No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR
  • T4 tumor invading any of the following:

    • Mediastinum
    • Heart
    • Great vessels
    • Trachea
    • Esophagus
    • Vertebral body
    • Carina
  • No brain, contralateral chest, liver, or adrenal metastases
  • No more than 1 parenchymal lesion
  • No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
  • No pericardial effusions
  • Measurable disease



  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Not specified


  • Creatinine clearance at least 50 mL/min


  • One of the following:

    • FEV1 at least 2.0 L
    • Predicted FEV1 of contralateral lung greater than 800 mL
    • Predicted post-treatment FEV1 at least 1.0 L


  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception


Biologic therapy:

  • No concurrent growth factors during induction chemoradiotherapy


  • No prior chemotherapy for lung cancer

Endocrine therapy:

  • Not specified


  • No prior radiotherapy for lung cancer


  • No prior surgical resection of lung cancer
  • Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00014196

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Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
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Study Chair: Raja Mudad, MD, FACP Tulane University Health Sciences Center

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Responsible Party: Southwest Oncology Group Identifier: NCT00014196    
Other Study ID Numbers: CDR0000068516
S0022 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: February 15, 2013
Last Verified: February 2013
Keywords provided by Southwest Oncology Group:
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action