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NCT Number: NCT00006469

Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA 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 these treatments before surgery may kill more tumor cells in patients with non-small cell lung cancer.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with radiation therapy before surgery in treating patients who have stage IIB non-small cell lung cancer or stage IIIA non-small cell lung cancer.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Washington Cancer Institute at Washington Hospital Center, Washington D.C., District of Columbia, United States

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About this study

OBJECTIVES:

  • Determine the response rate, duration of response, and survival in patients with bulky stage IIB or stage IIIA non-small cell lung cancer treated with paclitaxel, carboplatin, and radiotherapy followed by surgical resection.
  • Assess the toxicity of this regimen in this patient population.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 5 weeks. Patients also undergo concurrent radiotherapy daily 5 days a week for 5 weeks in the absence of unacceptable toxicity. At approximately 4 weeks after completion of chemoradiotherapy, patients with stable or regressive disease undergo surgical resection. If disease is unresectable, patients receive an additional 2 weeks of radiotherapy.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 29-30 patients will be accrued for this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Histologically confirmed bulky stage IIB or stage IIIA non-small cell lung cancer
  • Ipsilateral mediastinal node involvement by mediastinoscopy
  • No contralateral lymph node involvement
  • No malignant pleural effusion
  • No distant metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 10 g/dL

Hepatic:

  • ALT/AST less than 2 times upper limit of normal
  • Bilirubin no greater than 1.5 mg/dL

Renal:

  • Creatinine no greater than 2.0 mg/dL

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy

Surgery:

  • See Disease Characteristics

Treatment and study plan

carboplatin

Drug

Other names: paraplatin

paclitaxel

Drug

Other names: taxol

conventional surgery

Procedure

neoadjuvant therapy

Procedure

radiation therapy

Radiation

Primary outcomes

  1. Pathologic response rate

    Time frame: 3-5 Years

    as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment.

  2. Disease-free and overall survival at 3 and 5 years after completion of study treatment

    Time frame: 3-5 Years

Sponsors and collaborators

Lead sponsor

Medstar Health Research Institute

Other

Registry information

Official study title

Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) Non-small Cell Lung Cancer

Important dates

Study start
1999
Primary completion
2006
Study completion
2006
First posted
Jan 27, 2003
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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