Fludeoxyglucose F18 Positron Emission Tomography Imaging In Assessing Patients Before and After Treatment for Locally Advanced Non-Small Cell Lung Cancer

NCT00083083 | Unknown Phase 2

• 3 other identifiers: CDR0000362061ACRIN-6668RTOG-0235
• Study Type: interventional
• Target: 250
• Locations: 3 countries
• Sites: 49

Brief Summary

RATIONALE: Imaging procedures, such as fludeoxyglucose F18 positron emission tomography (\^18FDG-PET), may improve the ability to detect disease progression and help doctors predict a patient's response to treatment and plan more effective treatment. PURPOSE: This phase II trial is studying how well \^18FDG-PET imaging works in detecting disease progression and determining response to treatment in patients who are undergoing chemoradiotherapy for locally advanced non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage II non-small cell lung cancer; stage IIIA non-small cell lung cancer; stage IIIB non-small cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution

Secondary Outcomes (8)

• Relationship of survival to post-treatment max SUV as determined by the imaging institute

• Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution

• Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution

• Reliability between peak and max SUV measurements both pre- and post-treatment

• Proportion of participants who are either upstaged or downstaged by positron emission tomography scan

Interventions

carboplatin DRUG

cisplatin DRUG

docetaxel DRUG

etoposide DRUG

paclitaxel DRUG

vinblastine sulfate DRUG

vinorelbine tartrate DRUG

gene expression analysis GENETIC

positron emission tomography PROCEDURE

fludeoxyglucose F 18 RADIATION

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed non-small cell lung cancer (NSCLC) * Clinical stage IIB or III disease * No small cell carcinoma * No stage IV disease\* * No diffuse bronchoalveolar subtype * No planned definitive surgical resection NOTE: \*Patients with evidence of stage IV disease by positron emission tomography are eligible if the evidence cannot be confirmed by other means AND the physician still plans to proceed with definitive chemoradiation * Planning treatment with definitive chemoradiotherapy * May be treated on another Radiation Therapy Oncology Group protocol (except phase I studies) OR with conventional concurrent NSCLC chemoradiotherapy * Radiotherapy ≥ 60 Gy AND chemotherapy to include concurrent platinum-based therapy * No brain metastases by head CT scan or MRI PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 0-1 Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Not specified Renal * Not specified Other * Medically suitable for early concurrent chemoradiotherapy (radiotherapy dose ≥ 60 Gy) * Able to tolerate positron emission tomography imaging * No poorly controlled diabetes (defined as fasting glucose level \> 200 mg/dL) * No other malignancy within the past 3 years except basal cell or squamous cell skin cancer or carcinoma in situ * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy * No anticipated use of adjuvant biologic therapy beyond 14 weeks after the completion of radiotherapy Chemotherapy * See Disease Characteristics * No anticipated use of adjuvant chemotherapy beyond 14 weeks after the completion of radiotherapy Endocrine therapy * Not specified Radiotherapy * See Disease Characteristics * No prior thoracic radiotherapy * No concurrent intensity-modulated radiotherapy Surgery * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator
• Radiation Therapy Oncology Group: collaborator

Study Sites (49)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

Scottsdale Medical Imaging, Limited

Scottsdale, Arizona, 85262, United States

Location

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Radiological Associates of Sacramento Medical Group at Sutter Cancer Center

Sacramento, California, 95816, United States

Location

Hospital of Saint Raphael

New Haven, Connecticut, 06511, United States

Location

Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital

Boynton Beach, Florida, 33435, United States

Location

North Broward Medical Center

Dearfield Beach, Florida, 33064-3596, United States

Location

Integrated Community Oncology Network at Baptist Cancer Institute

Jacksonville, Florida, 32207, United States

Location

Tallahassee Memorial Hospital

Tallahassee, Florida, 32308, United States

Location

Rush Cancer Institute at Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Saint John's Cancer Center at Saint John's Medical Center

Anderson, Indiana, 46016, United States

Location

Center for Cancer Care at Goshen General Hospital

Goshen, Indiana, 46526, United States

Location

CCOP - Northern Indiana CR Consortium

South Bend, Indiana, 46601, United States

Location

Greenebaum Cancer Center at University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Dana-Farber Partners Cancer Care

Boston, Massachusetts, 02129, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

South Shore Hospital

South Weymouth, Massachusetts, 02190, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007-3731, United States

Location

William Beaumont Hospital - Royal Oak Campus

Royal Oak, Michigan, 48073, United States

Location

Mallinckrodt Institute of Radiology at Washington University Medical Center

St Louis, Missouri, 63110, United States

Location

Renown Institute for Cancer at Renown Regional Medical Center

Reno, Nevada, 89502, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital

Teaneck, New Jersey, 07666, United States

Location

J. Phillip Citta Regional Cancer Center at Community Medical Center

Toms River, New Jersey, 08755, United States

Location

McDowell Cancer Center at Akron General Medical Center

Akron, Ohio, 44302, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Knight Cancer Institute at Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Kimmel Cancer Center at Thomas Jefferson University - Philadelphia

Philadelphia, Pennsylvania, 19107-5541, United States

Location

Fox Chase Cancer Center - Philadelphia

Philadelphia, Pennsylvania, 19111-2497, United States

Location

Albert Einstein Cancer Center

Philadelphia, Pennsylvania, 19141, United States

Location

UPMC Cancer Centers

Pittsburgh, Pennsylvania, 15232, United States

Location

Lankenau Cancer Center at Lankenau Hospital

Wynnewood, Pennsylvania, 19096, United States

Location

Roger Williams Medical Center

Providence, Rhode Island, 02908-4735, United States

Location

Brown University School of Medicine

Providence, Rhode Island, 02912, United States

Location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Gibbs Regional Cancer Center at Spartanburg Regional Medical Center

Spartanburg, South Carolina, 29303, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

M. D. Anderson Cancer Center at University of Texas

Houston, Texas, 77030-4009, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Bon Secours Cancer Institute at St. Mary's Hospital

Richmond, Virginia, 23226, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Waukesha Memorial Hospital Regional Cancer Center

Waukesha, Wisconsin, 53188, United States

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Grand River Regional Cancer Centre at Grand River Hospital

Kitchner, Ontario, N2G 1G3, Canada

Location

National Cancer Center - Korea

Goyang, 410-769, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Cisplatin; Docetaxel; Etoposide; Paclitaxel; Vinblastine; Vinorelbine; Gene Expression Profiling; Magnetic Resonance Spectroscopy; Fluorodeoxyglucose F18; Radiotherapy

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Genetic Techniques; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Deoxyglucose; Deoxy Sugars; Therapeutics

Study Officials

• Mitchell Machtay, MD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 14, 2004
• First Posted: May 17, 2004
• Study Start: March 1, 2005
• Primary Completion: June 1, 2006
• Last Updated: March 1, 2011

Record last verified: 2007-10

Locations

US (46); CA (2); KR (1)