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Study of Positron Emission Tomography and Computed Tomography in Guiding Radiation Therapy in Patients With Stage III Non-Small Cell Lung Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Cancer Institute (NCI)
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01507428
First received: January 5, 2012
Last updated: June 16, 2014
Last verified: April 2014
  Purpose

This randomized phase II trial studies how well positron emission tomography (PET)/computed tomography (CT) scan work in guiding radiation therapy compared to standard radiation therapy treatment in patients with stage III non-small cell lung cancer. Imaging procedures, such as PET scan and CT scan, may help doctors plan radiation therapy for patients with non-small cell lung cancer.


Condition Intervention Phase
Adenocarcinoma of the Lung
Adenosquamous Cell Lung Cancer
Bronchoalveolar Cell Lung Cancer
Large Cell Lung Cancer
Squamous Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Radiation: external beam radiation therapy
Radiation: image-guided adaptive radiation therapy
Drug: paclitaxel
Drug: carboplatin
Radiation: fludeoxyglucose F 18
Procedure: positron emission tomography
Procedure: computed tomography
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Phase II Trial of Individualized Adaptive Radiotherapy Using During-Treatment FDG-PET/CT and Modern Technology in Locally Advanced Non-small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Local-regional, progression-free (LRPF) rate (RTOG) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Relative change in SUV peak from the baseline to the during-treatment FDG-PET/CT to LRPF (ACRIN) [ Time Frame: Baseline to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to local-regional progression (TTLRP) (RTOG) [ Time Frame: Interval from registration to date of local or regional progression, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival (OS) (RTOG) [ Time Frame: Interval from registration to the date of death or censored at the date of data collection, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS) (RTOG) [ Time Frame: Interval from the date of registration to the date of tumor progression locally, regionally, distantly, or death, whichever occurs first, or censored at the last date of data collection, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Lung cancer cause-specific survival (RTOG) [ Time Frame: Interval from the date of registration to the date of death directly from lung cancer, or censored at the last date of data collection if still alive, assessed up to 5 years ] [ Designated as safety issue: No ]
  • Radiation-induced lung toxicity (RILT) (RTOG) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Incidence of grade 3+ esophagitis or cardiac adverse events related to chemoradiation between a conventional RT plan and a PET/CT-guided adaptive RT plan, as measured by Common Terminology Criteria for Adverse Events (CTCAE), v. 4 (RTOG) [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Baseline FMISO uptake (tumor-to-blood pool ratio) association with LRPF (i.e. the assessment of using baseline FMISO-PET uptake as a prognostic marker) (ACRIN) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Relative change in SUV peak from the baseline to the during-treatment FDG PET/CT and/or the baseline FMISO uptake (tumor-to-blood pool ratio) prediction of the differential benefit of the adaptive therapy (ACRIN) [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
  • Change of peak SUVs for FDG from pre- to during-treatment (ACRIN) [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
  • Max SUV or change of max SUVs for FDG from pre- to during-treatment (ACRIN) [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
  • Change in metabolic tumor volume (ACRIN) [ Time Frame: Baseline to up to 5 years ] [ Designated as safety issue: No ]
  • FMISO total hypoxic volume (ACRIN) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • FMISO tumor-to-blood pool ratio (ACRIN) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Prediction of OS, LRPF, and lung cancer cause-specific (LCS) survival (ACRIN) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Optimal threshold for differentiating responders from non-responders (ACRIN) [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 138
Study Start Date: February 2012
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm I (standard chemoradiotherapy)
Patients undergo radiotherapy QD 5 days a weeks for 6 weeks. Patients also receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes once weekly for 6 weeks.
Radiation: external beam radiation therapy
Undergo radiotherapy
Other Name: EBRT
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Undergo FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG PET/CT
Other Name: tomography, computed
Other: laboratory biomarker analysis
Correlative studies
Experimental: Arm II (experimental chemoradiotherapy)
Patients undergo image-guided radiotherapy QD 5 days a week for 6 weeks. Based on the FDG-PET/CT scan results, patients undergo individualized adaptive radiotherapy for 2-3 weeks. Patients also receive paclitaxel and carboplatin as in arm I.
Radiation: image-guided adaptive radiation therapy
Undergo individualized adaptive radiotherapy
Other Names:
  • IGART
  • image-guided adaptive radiotherapy
Drug: paclitaxel
Given IV
Other Names:
  • Anzatax
  • Asotax
  • TAX
  • Taxol
Drug: carboplatin
Given IV
Other Names:
  • Carboplat
  • CBDCA
  • JM-8
  • Paraplat
  • Paraplatin
Radiation: fludeoxyglucose F 18
Undergo FDG PET/CT
Other Names:
  • 18FDG
  • FDG
Procedure: positron emission tomography
Undergo FDG PET/CT
Other Names:
  • FDG-PET
  • PET
  • PET scan
  • tomography, emission computed
Procedure: computed tomography
Undergo FDG PET/CT
Other Name: tomography, computed
Other: laboratory biomarker analysis
Correlative studies

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  • Patients must have FDG-avid (maximum SUV >= 4.0) (from PET scan of any date, any scanner) and histologically or cytologically proven non-small cell lung cancer
  • Patients must be clinical stage IIIA or IIIB (American Joint Committee on Cancer [AJCC], 7th ed.) with non-operable disease; non-operable disease will be determined by a multi-disciplinary treatment team, involving evaluation by at least 1 thoracic surgeon within 8 weeks prior to registration; Note: For patients who are clearly nonresectable, the case can be determined by the treating radiation oncologist and a medical oncologist, or pulmonologist
  • Patients with multiple, ipsilateral pulmonary nodules (T3 or T4) are eligible if a definitive course of daily fractionated radiation therapy (RT) is planned
  • History/physical examination, including documentation of weight, within 2 weeks prior to registration
  • FDG-PET/CT scan for staging and RT plan within 4 weeks prior to registration
  • CT scan or sim CT of chest and upper abdomen (IV contrast is recommended unless medically contraindicated) within 6 weeks prior to registration
  • CT scan of the brain (contrast is recommended unless medically contraindicated) or MRI of the brain within 6 weeks prior to registration
  • Pulmonary function tests, including diffusion capacity of carbon monoxide (DLCO), within 6 weeks prior to registration; patients must have forced expiratory volume in 1 second (FEV1) >= 1.2 Liter or >= 50% predicted without bronchodilator
  • Zubrod performance status 0-1
  • Able to tolerate PET/CT imaging required to be performed at an American College of Radiology Imaging Network (ACRIN) qualified facility
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3
  • Platelets >= 100,000 cells/mm^3
  • Hemoglobin (Hgb) >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb >= 10.0 g/dl is acceptable)
  • Serum creatinine within normal institutional limits or a creatinine clearance >= 60 ml/min within 2 weeks prior to registration
  • Negative serum or urine pregnancy test within 3 days prior to registration for women of childbearing potential
  • Women of childbearing potential and male participants must agree to use a medically effective means of birth control throughout their participation in the treatment phase of the study
  • The patient must provide study-specific informed consent prior to study entry

Exclusion Criteria:

  • Patients with any component of small cell lung carcinoma are excluded
  • Patients with evidence of a malignant pleural or pericardial effusion are excluded
  • Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (for example, carcinoma in situ of the breast, oral cavity, or cervix are all permissible)
  • Prior systemic chemotherapy for the study cancer; note that prior chemotherapy for a different cancer is allowable
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields
  • Severe, active co-morbidity, defined as follows:

    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
    • Transmural myocardial infarction within the last 6 months
    • Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
    • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
    • Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
    • Acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control (CDC) definition; note, however, that human immunodeficiency virus (HIV) testing is not required for entry into this protocol
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception
  • Poorly controlled diabetes (defined as fasting glucose level > 200 mg/dL) despite attempts to improve glucose control by fasting duration and adjustment of medications
  • For 18F-fluoromisonidazole (FMISO)-PET/CT: patient is unable to undergo this imaging
  • Patients with T4 disease with radiographic evidence of massage invasion of a large pulmonary artery and tumor causing significant narrowing and destruction of that artery are excluded
  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: NCT01507428

Locations
United States, California
Stanford University Hospitals and Clinics Recruiting
Stanford, California, United States, 94305
Contact: Billy W. Loo    650-498-7061    ccto-office@stanford.edu   
Principal Investigator: Billy W. Loo         
United States, Georgia
Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: John G. Stewart    706-721-1663    cancer@georgiahealth.edu   
Principal Investigator: John G. Stewart         
United States, Kentucky
The James Graham Brown Cancer Center at University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Neal E. Dunlap    866-530-5516      
Principal Investigator: Neal E. Dunlap         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Matthew H. Stenmark    800-865-1125      
Principal Investigator: Matthew H. Stenmark         
United States, Mississippi
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: James T. Thigpen    601-815-6700      
Principal Investigator: James T. Thigpen         
United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Jeffrey D. Bradley    800-600-3606    info@siteman.wustl.edu   
Principal Investigator: Jeffrey D. Bradley         
United States, Ohio
Case Western Reserve University Active, not recruiting
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation Active, not recruiting
Cleveland, Ohio, United States, 44195
United States, Oklahoma
University of Oklahoma Health Sciences Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Terence S. Herman    405-271-4272    julie-traylor@ouhsc.edu   
Principal Investigator: Terence S. Herman         
United States, Pennsylvania
Reading Hospital Recruiting
West Reading, Pennsylvania, United States, 19611
Contact: Albert Yuen    610-988-9323      
Principal Investigator: Albert Yuen         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: James G. Ravenel    843-792-9321      
Principal Investigator: James G. Ravenel         
United States, Wisconsin
Froedtert and the Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Elizabeth M. Gore    888-469-6614      
Principal Investigator: Elizabeth M. Gore         
Canada, Quebec
McGill University Department of Oncology Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Sergio L. Faria    514-934-1934ext42953    evelyn.ortega@muhc.mcgill.ca   
Principal Investigator: Sergio L. Faria         
Sponsors and Collaborators
Investigators
Principal Investigator: Feng-Ming (Spring) Kong Radiation Therapy Oncology Group
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01507428     History of Changes
Other Study ID Numbers: NCI-2012-00107, NCI-2012-00107, CDR0000721619, RTOG-1106/ACRIN-6697, RTOG 1106/ACRIN 6697, RTOG-1106, U10CA180868, U10CA021661
Study First Received: January 5, 2012
Last Updated: June 16, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Carboplatin
Paclitaxel
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Pharmacologic Actions
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on August 01, 2014