Full Text View
Tabular View
No Study Results Posted
Related Studies
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
This study has been completed.
Study NCT00014196   Information provided by National Cancer Institute (NCI)
First Received: April 10, 2001   Last Updated: February 6, 2009   History of Changes

April 10, 2001
February 6, 2009
March 2001
 
 
 
Complete list of historical versions of study NCT00014196 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer
Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer

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.

OBJECTIVES:

  • 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.

Phase II
Interventional
Treatment
Lung Cancer
  • Drug: cisplatin
  • Drug: docetaxel
  • Radiation: radiation therapy
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
 

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance at least 50 mL/min

Pulmonary:

  • 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

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent growth factors during induction chemoradiotherapy

Chemotherapy:

  • No prior chemotherapy for lung cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lung cancer

Surgery:

  • No prior surgical resection of lung cancer
  • Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00014196
 
CDR0000068516, SWOG-S0022
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Raja Mudad, MD, FACP Tulane University Health Sciences Center
National Cancer Institute (NCI)
June 2002

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP