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Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

Primary Purpose

Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
carboplatin
paclitaxel
radiation therapy
Sponsored by
Baptist Health South Florida
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer focused on measuring stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Patients with unresected locally advanced non-small cell lung cancer Stage II, IIIA, or IIIB No evidence of hematogenous metastases No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 130,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active or symptomatic cardiac disease No acute myocardial infarction within the past 6 months No angina No congestive heart failure No uncontrolled arrhythmias Cardiac ejection fraction greater than 50% Pulmonary: FEV1 at least 1.25 L AND DLCO at least 50% predicted Other: Not pregnant Fertile patients must use effective contraception Weight loss no greater than 5% within 3 months of diagnosis No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy Surgery: See Disease Characteristics

Sites / Locations

  • Sylvester Cancer Center, University of Miami
  • Baptist Hospital of Miami

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 28, 2000
Last Updated
December 17, 2013
Sponsor
Baptist Health South Florida
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1. Study Identification

Unique Protocol Identification Number
NCT00004253
Brief Title
Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery
Official Title
A Phase II Study of 3-Dimensional Conformal Hyperfractionation Radiation Therapy (3D-CHRT) With Dose Escalation and Amifostine Mucosal Protection for Patients With Favorable Prognosis Inoperable Stage II-IIIA/B Non-Small Cell Lung Cancer (NSCLC) Receiving Paclitaxel and Carboplatin
Study Type
Interventional

2. Study Status

Record Verification Date
November 2002
Overall Recruitment Status
Unknown status
Study Start Date
March 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Baptist Health South Florida

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Specialized radiation therapy delivers a high dose of radiation directly to the tumor which may kill more tumor cells and cause less damage to normal tissue. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and specialized high-dose radiation therapy in treating patients who have stage II or stage III non-small cell lung cancer that cannot be removed by surgery.
Detailed Description
OBJECTIVES: Determine the probability of overall survival and local control in patients with favorable prognosis, unresectable stage II-IIIA/B non-small cell lung cancer receiving paclitaxel and carboplatin plus 3-D conformal hyperfractionation radiotherapy (3D-CHRT). Determine the incidence and severity of nonhematologic toxicity, specifically esophagitis and pneumonitis, during 3D-CHRT and chemotherapy with paclitaxel and carboplatin in these patients. Correlate complication rate with radiation based on the effective dose to determine safe treatment guidelines. Determine the feasibility of patient-specific dose escalation using this regimen in these patients. Determine the quality of life and symptom distress in these patients on this regimen. OUTLINE: This is a dose-escalation study of 3-D conformal hyperfractionated radiotherapy (3D-CHRT). Patients receive paclitaxel IV over 1 hour followed immediately by carboplatin IV over 30 minutes weekly for 6-8 weeks. Patients undergo 3D-CHRT twice daily five days a week for 6-8 weeks. Cohorts of patients receive escalating doses of 3D-CHRT in 4 dose levels. Quality of life is assessed prior to study, weekly during chemotherapy and radiotherapy, and at 3 and 6 months. Patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years and then annually thereafter. PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Type
Radiation
Intervention Name(s)
radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Patients with unresected locally advanced non-small cell lung cancer Stage II, IIIA, or IIIB No evidence of hematogenous metastases No pleural effusion(s) on chest x-ray (except after a thoracotomy or other invasive thoracic procedure) No intrathoracic tumor recurrence following resection PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 130,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 1.5 times upper limit of normal (unless caused by documented benign disease) Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active or symptomatic cardiac disease No acute myocardial infarction within the past 6 months No angina No congestive heart failure No uncontrolled arrhythmias Cardiac ejection fraction greater than 50% Pulmonary: FEV1 at least 1.25 L AND DLCO at least 50% predicted Other: Not pregnant Fertile patients must use effective contraception Weight loss no greater than 5% within 3 months of diagnosis No other prior malignancy within the past 3 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior thoracic or neck radiotherapy Surgery: See Disease Characteristics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andre A. Abitbol, MD
Organizational Affiliation
Baptist Health South Florida
Official's Role
Study Chair
Facility Information:
Facility Name
Sylvester Cancer Center, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Baptist Hospital of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33176-2197
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage II or Stage III Non-small Cell Lung Cancer That Cannot Be Removed By Surgery

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