Combination Chemotherapy and Radiation Therapy Followed By Surgery in Treating Patients With Stage IIB or Stage IIIA Non-Small Cell Lung Cancer

Phase II Trial of Concurrent Paclitaxel, Carboplatin and External Beam Radiotherapy Followed by Surgical Resection in Stage IIIA (N2) 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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: carboplatin; Radiation: radiation therapy; Procedure: neoadjuvant therapy; Procedure: conventional surgery; Drug: paclitaxel

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Washington Cancer Institute at Washington Hospital Center
  • Maryland
    • Baltimore, Maryland, United States, 21237
      • Harry and Jeanette Weinberg Cancer Institute at Franklin Square Hospital Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Single arm study; Concurrent Paclitaxel, Carboplatin, and External-Beam Radiation Followed by Surgical Resection in Locally Advanced Non-Small-Cell Lung Cancer	Drug: carboplatin; Other Names: paraplatin; Radiation: radiation therapy; Procedure: neoadjuvant therapy; Procedure: conventional surgery; Drug: paclitaxel; Other Names: taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathologic response rate	as measured by pathology of the resected specimen and chest x-ray at 3 and 5 years after completion of study treatment.	3-5 Years
Disease-free and overall survival at 3 and 5 years after completion of study treatment		3-5 Years

Collaborators and Investigators

• Sponsor: Medstar Health Research Institute

Study record dates

Study Major Dates

• Study Start: August 1, 1999
• Primary Completion (Actual): January 30, 2006
• Study Completion (Actual): January 30, 2006

Study Registration Dates

• First Submitted: November 6, 2000
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Actual): August 19, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: stage IIIA non-small cell lung cancer; stage II non-small cell lung cancer
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Carboplatin; Paclitaxel
• Other Study ID Numbers: CDR0000068288; WHC-99444; NCI-V00-1632