Specialized Radiation Therapy and Chemotherapy in Treating Patients With Stage III Non-Small Cell Lung Cancer That Cannot Be Removed by Surgery

This study is currently recruiting participants.
Verified December 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01486602
First received: December 2, 2011
Last updated: December 6, 2012
Last verified: December 2012
  Purpose

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving specialized radiation therapy together with chemotherapy may kill more tumor cells.

PURPOSE: This phase I trial studies the side effects and the best dose of specialized radiation therapy giving together with chemotherapy in treating patients with stage III non-small cell lung cancer that cannot be removed by surgery.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Radiation: 3-dimensional conformal radiation therapy
Radiation: hypofractionated radiation therapy
Radiation: intensity-modulated radiation therapy
Phase 1

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Accelerated Hypofractionated Radiation Therapy With Concomitant Chemotherapy for Unresectable Stage III Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum-tolerated RT dose fraction [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Radiographic response [ Designated as safety issue: No ]
  • Metabolic response [ Designated as safety issue: No ]
  • Rates of progression: local/regional/distant [ Designated as safety issue: No ]
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: March 2012
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To determine the maximum-tolerable radiotherapy (RT) dose fraction for accelerated hypofractionated radiotherapy with concurrent chemotherapy.

Secondary

  • To evaluate the rate of radiographic response to treatment.
  • To estimate the rates of progression: local/regional/distant.
  • To estimate the progression-free survival.
  • To estimate the overall survival.

OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy.

Concurrent therapy: Patients receive paclitaxel IV over 60 minutes and carboplatin IV over 30-60 minutes on days 1 and 8. Treatment repeats every 14 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo accelerated hypofractionated radiotherapy using 3-dimensional conformal radiation therapy or intensity-modulated radiotherapy (IMRT) once daily, 5 days a week, for approximately 4 to 5.5 weeks.

Consolidation therapy: Beginning 4 weeks after completion of radiotherapy, patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically documented non-small cell lung cancer (NSCLC)
  • Stage: IIIA or IIIB NSCLC; patients who present with N2 or N3 disease and an undetectable primary tumor are also eligible
  • Tumor Site: Thoracic disease without supraclavicular or contralateral hilar involvement
  • Pleural Effusion: When pleural fluid is visible on both computed tomography (CT) scan and on a chest x-ray, a pleuracentesis is required to confirm that the pleural fluid is cytologically negative

    • Exudative pleural effusions are excluded regardless of cytology
    • Patients with effusions that are minimal (i.e., not visible on chest x-ray) and too small to safely tap are eligible
  • Patients must have measurable disease

    • Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 2 cm with conventional techniques or as ≥ 1 cm with spiral CT scan
    • Patients with non-measurable disease are not eligible; all other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions; lesions that are considered non-measurable include the following:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • No patients that are known to be pregnant or nursing
  • Granulocytes ≥ 1,500/μl
  • Platelet count ≥ 100,000/μl
  • Bilirubin ≤1.5 times upper limit of normal (ULN)
  • AST (SGOT) ≤ 2.0 times ULN
  • Serum creatinine ≤ 1.5 times ULN OR calculated creatinine clearance ≥ 70 mL/min
  • FEV-1 ≥ 1.2 L/sec or 50% predicted

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy or chemotherapy for non-small cell lung cancer (NSCLC)
  • No prior mediastinal or thoracic radiotherapy
  • Patients with complete surgical resection of disease are not eligible, however; patients with surgical resection and measurable gross residual disease present on imaging are considered eligible
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486602

Locations
United States, Arizona
Mayo Clinic Hospital Recruiting
Phoeniz, Arizona, United States, 85054
Contact: Steven E. Schild, MD    507-538-1760      
Mayo Clinic Scottsdale Recruiting
Scottsdale, Arizona, United States, 85259-5499
Contact: Clinical Trials Office - All Mayo Clinic Locations    507-538-7623      
United States, California
Rebecca and John Moores UCSD Cancer Center Recruiting
La Jolla, California, United States, 92093-0658
Contact: Clinical Trials Office - Rebecca and John Moores UCSD Cancer    858-822-5354    cancercto@ucsd.edu   
United States, Illinois
University of Chicago Cancer Research Center Recruiting
Chicago, Illinois, United States, 60637-1470
Contact: Clinical Trials Office - University of Chicago Cancer Research    773-834-7424      
United States, New York
SUNY Upstate Medical University Hospital Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi    315-464-5476      
United States, North Carolina
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599-7295
Contact: Clinical Trials Office - Lineberger Comprehensive Cancer Cente    877-668-0683; 919-966-4432      
Wake Forest University Comprehensive Cancer Center Recruiting
Winston-Salem, North Carolina, United States, 27157-1096
Contact: Clinical Trials Office - Wake Forest University Comprehensive    336-713-6771      
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Principal Investigator: James J. Urbanic, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
No publications provided

Responsible Party: Monica M. Bertagnolli, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier: NCT01486602     History of Changes
Other Study ID Numbers: CDR0000719011, CALGB-31102
Study First Received: December 2, 2011
Last Updated: December 6, 2012
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carboplatin
Paclitaxel
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on April 17, 2014