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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

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.
 
ClinicalTrials.gov Identifier: NCT00004253
Recruitment Status : Unknown
Verified November 2002 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : July 23, 2003
Last Update Posted : December 18, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment Phase
Lung Cancer Drug: carboplatin Drug: paclitaxel Radiation: radiation therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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 Start Date : March 2000

Resource links provided by the National Library of Medicine

Drug Information available for: Carboplatin





Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT00004253


Locations
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United States, Florida
Sylvester Cancer Center, University of Miami
Miami, Florida, United States, 33136
Baptist Hospital of Miami
Miami, Florida, United States, 33176-2197
Sponsors and Collaborators
Baptist Health South Florida
Investigators
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Study Chair: Andre A. Abitbol, MD Baptist Health South Florida
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ClinicalTrials.gov Identifier: NCT00004253    
Other Study ID Numbers: CDR0000067500
BHM-L1
BHM-99-64
NCI-V99-1582
First Posted: July 23, 2003    Key Record Dates
Last Update Posted: December 18, 2013
Last Verified: November 2002
Keywords provided by National Cancer Institute (NCI):
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action