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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.
Verified March 2013 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: March 6, 2013
Last verified: March 2013
History of Changes
  Purpose

This randomized phase II trial studies how well PET/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 positron emission tomography (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:

U.S. FDA Resources

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 ]
  • 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 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 3-4 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) and histologically or cytologically proven non-small cell lung cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507428

Locations
United States, Michigan
University of Michigan University Hospital Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Feng-Ming (Spring) P. Kong     800-865-1125        
Principal Investigator: Feng-Ming (Spring) P. Kong            
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 Recruiting
Cleveland, Ohio, United States, 44106
Contact: Mitchell Machtay     800-641-2422        
Principal Investigator: Mitchell Machtay            
United States, Pennsylvania
Radiation Therapy Oncology Group Not yet recruiting
Philadelphia, Pennsylvania, United States, 19103
Contact: Feng-Ming (Spring) P. Kong     734-936-7810     fengkong@med.umich.edu    
Principal Investigator: Feng-Ming (Spring) P. Kong            
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            
Sponsors and Collaborators
National Cancer Institute (NCI)
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, RTOG-1106, U10CA021661, CDR0000721619
Study First Received: January 5, 2012
Last Updated: March 6, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lung Neoplasms
Adenocarcinoma
Adenocarcinoma, Mucinous
Adenocarcinoma, Bronchiolo-Alveolar
Carcinoma, Non-Small-Cell Lung
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Cystic, Mucinous, and Serous
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
 Neoplasms by Site
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 May 19, 2013