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

This study has suspended participant recruitment.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01486602
First received: December 2, 2011
Last updated: August 20, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to test the safety of radiation therapy given at increased doses in a shorter period of time in order to find out what effects, good and/or bad, it has on the patient and the lung cancer. The standard way of giving the radiation therapy is to give it once daily for 6 to 7 weeks. The study is currently testing if a higher amount of radiation therapy per treatment can be given as well as shorten the total number of treatments to 4 or 5 weeks. The goal is that a higher dose of radiation therapy per treatment will be more effective than current standard treatments. In addition to the radiation treatment, patients will receive chemotherapy with carboplatin and paclitaxel, which are standard drugs for treating lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: carboplatin
Drug: paclitaxel
Radiation: radiation therapy
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
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 Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • Maximum-tolerated RT dose fraction [ Time Frame: Up to 28 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Radiographic response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Metabolic response [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Rates of progression: local/regional/distant [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 5 years ] [ 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)
Arms Assigned Interventions
Experimental: Concurrent therapy + consolidation therapy

Concurrent Therapy (1 cycle = 14 days, Cycles 1-3): Patients will receive paclitaxel 45 mg/m^2 by IV over 1 hour weekly followed by carboplatin AUC 2 by IV over 30-60 minutes for 4 weeks (there will be no chemotherapy during Cycle 3). Patients will receive radiotherapy concurrently for up to 5.5 weeks, depending on the cohorts the patient is registered defined per the protocol.

Consolidation Therapy (1 cycle = 21 days, Cycles 4-5): Four weeks following the end of radiotherapy patients will receive paclitaxel 200 mg/m^2 by IV over 3 hours followed by carboplatin AUC 6 by IV over 30-60 minutes on day 1 of each 21 day cycle for a total of 2 cycles (days 1 and 22).

Drug: carboplatin
IV
Drug: paclitaxel
IV
Radiation: radiation therapy
Defined per the protocol

Detailed Description:

OUTLINE: This is a multicenter, dose-escalation study of accelerated hypofractionated radiotherapy. Protocol therapy will consist of accelerated hypofractionated radiotherapy given with concurrent chemotherapy for two cycles. Consolidative chemotherapy will be given for two cycles after the completion of concurrent therapy. Patients will also receive premedications for paclitaxel as defined in the protocol.

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.

A maximum of 5 years follow up is required for all patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  1. Documentation of Disease (American Joint Committee on Cancer Version 7)

    • 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 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) too small to safely tap are eligible.

  2. Prior Treatment

    • No prior radiotherapy or chemotherapy for 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.
  3. 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 non-measurable 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
  4. Age ≥ 18 years
  5. ECOG Performance Status 0-1
  6. No patients that are known to be pregnant or nursing.
  7. Required Initial Laboratory Values:

    • Granulocytes ≥ 1,500/μl
    • Platelet count ≥ 100,000/μl
    • Bilirubin ≤ 1.5 x ULN
    • AST (SGOT) ≤ 2.0 x ULN
    • Serum Creatinine ≤ 1.5 x ULN or
    • Calculated Creatinine Clearance ≥ 70 ml/min
    • FEV-1 ≥ 1.2 liters/second or 50% predicted
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486602

Locations
United States, Arizona
Mayo Clinic Hospital
Phoeniz, Arizona, United States, 85054
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259
United States, California
Moores University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0987
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Maryland
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, New York
State University of New York Upstate Medical University
Syracuse, New York, United States, 13210
United States, North Carolina
University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States, 27599-7305
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157-1030
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: James J. Urbanic, MD Wake Forest School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT01486602     History of Changes
Other Study ID Numbers: CALGB 31102, CDR0000719011, NCI-2012-00087
Study First Received: December 2, 2011
Last Updated: August 20, 2014
Health Authority: United States: NCI Central Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Alliance for Clinical Trials in Oncology:
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014