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

Sponsor:	American College of Radiology Imaging Network
Collaborators:	National Cancer Institute (NCI) Radiation Therapy Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00083083

Purpose

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.

Condition	Intervention	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: paclitaxel Drug: vinblastine Drug: vinorelbine ditartrate Genetic: gene expression analysis Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: radiation therapy	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
Official Title:	Positron Emission Tomography Pre- and Post-Treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Health Facilities Lung Cancer

Drug Information available for: Cisplatin Paclitaxel Etoposide Carboplatin Fluorodeoxyglucose F18 Vinorelbine Docetaxel Etoposide phosphate Vinorelbine tartrate Vinblastine sulfate Vinblastine

U.S. FDA Resources

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

Primary Outcome Measures:

Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relationship of survival to post-treatment max SUV as determined by the imaging institute [ Designated as safety issue: No ]
Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution [ Designated as safety issue: No ]
Reliability between peak and max SUV measurements both pre- and post-treatment [ Designated as safety issue: No ]
Proportion of participants who are either upstaged or downstaged by positron emission tomography scan [ Designated as safety issue: No ]
Reliability between PET scan-defined response to therapy measurements [ Designated as safety issue: No ]
Correlation of Ki-67 expression with peak and max pre-treatment SUV [ Designated as safety issue: No ]
Association between Ki-67 expression and overall survival at 2 years [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	March 2005
Estimated Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

Determine whether peak standardized uptake value (SUV) for fludeoxyglucose F 18 positron emission tomography (FDG-PET) shortly after definitive chemoradiotherapy is predictive of long-term survival of patients with inoperable stage IIB or III non-small cell lung cancer.

Secondary

Determine whether max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of long-term survival in these patients.
Determine whether post-treatment imaging using peak and max SUV for FDG-PET shortly after definitive chemoradiotherapy is predictive of local disease control in these patients.
Determine whether pre-treatment imaging using these techniques is predictive of long-term survival and local disease control in these patients.
Correlate, if possible, Ki-67 expression with overall survival of patients assessed with these imaging techniques.

OUTLINE: This is a diagnostic, multicenter study.

Before starting chemoradiotherapy, patients undergo baseline whole-body positron emission tomography (PET) imaging. Patients receive fludeoxyglucose F 18 (^18FDG) IV followed 50-70 minutes later by PET imaging. Patients then receive concurrent definitive radiotherapy and chemotherapy. Patients enrolled in other treatment-oriented clinical trials receive therapy as per that trial. Other patients receive standard thoracic radiotherapy (dose ≥ 60 Gy) and standard chemotherapy comprising a platin (cisplatin or carboplatin) and a second non-platin, non-gemcitabine drug (etoposide, vinblastine, vinorelbine, paclitaxel, or docetaxel). Approximately 14 weeks after completion of chemoradiotherapy and adjuvant chemotherapy (if given), patients undergo post-treatment ^18FDG-PET imaging.

Patients are followed every 3 months for 2 years and then every 6 months for at least 1 year.

PROJECTED ACCRUAL: A total of 250 patients (including at least 75 with stage IIB/IIIA disease and at least 75 with stage IIIB disease) will be accrued for this study within 2 years.

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00083083

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Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Scottsdale Medical Imaging, Limited
Scottsdale, Arizona, United States, 85262
United States, California
Radiological Associates of Sacramento Medical Group at Sutter Cancer Center
Sacramento, California, United States, 95816
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Connecticut
Hospital of Saint Raphael
New Haven, Connecticut, United States, 06511
United States, Florida
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital
Boynton Beach, Florida, United States, 33435
Integrated Community Oncology Network at Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
North Broward Medical Center
Dearfield Beach, Florida, United States, 33064-3596
Tallahassee Memorial Hospital
Tallahassee, Florida, United States, 32308
United States, Illinois
Rush Cancer Institute at Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Care at Goshen General Hospital
Goshen, Indiana, United States, 46526
Saint John's Cancer Center at Saint John's Medical Center
Anderson, Indiana, United States, 46016
United States, Maryland
Greenebaum Cancer Center at University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Dana-Farber Partners Cancer Care
Boston, Massachusetts, United States, 02129
South Shore Hospital
South Weymouth, Massachusetts, United States, 02190
United States, Michigan
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007-3731
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Missouri
Mallinckrodt Institute of Radiology at Washington University Medical Center
St. Louis, Missouri, United States, 63110
United States, Nevada
Renown Institute for Cancer at Renown Regional Medical Center
Reno, Nevada, United States, 89502
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
United States, New Jersey
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States, 08755
Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, Ohio
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
McDowell Cancer Center at Akron General Medical Center
Akron, Ohio, United States, 44302
United States, Oklahoma
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Knight Cancer Institute at Oregon Health and Science University
Portland, Oregon, United States, 97239-3098
United States, Pennsylvania
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States, 19141
Fox Chase Cancer Center - Philadelphia
Philadelphia, Pennsylvania, United States, 19111-2497
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, United States, 19107-5541
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
UPMC Cancer Centers
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Brown University School of Medicine
Providence, Rhode Island, United States, 02912
Roger Williams Medical Center
Providence, Rhode Island, United States, 02908-4735
United States, South Carolina
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Utah
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, United States, 84112
United States, Virginia
Bon Secours Cancer Institute at St. Mary's Hospital
Richmond, Virginia, United States, 23226
United States, Wisconsin
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792-6164
Waukesha Memorial Hospital Regional Cancer Center
Waukesha, Wisconsin, United States, 53188
Canada, Alberta
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada, T2N 4N2
Canada, Ontario
Grand River Regional Cancer Centre at Grand River Hospital
Kitchner, Ontario, Canada, N2G 1G3
Korea, Republic of
National Cancer Center - Korea
Goyang, Korea, Republic of, 410-769

Sponsors and Collaborators

American College of Radiology Imaging Network

National Cancer Institute (NCI)

Radiation Therapy Oncology Group

Investigators

Study Chair:	Mitchell Machtay, MD	Kimmel Cancer Center (KCC)
Study Chair:	Mitchell Machtay, MD	Kimmel Cancer Center (KCC)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia ( Mitchell Machtay )
Study ID Numbers:	CDR0000362061, ACRIN-6668, RTOG-0235
Study First Received:	May 14, 2004
Last Updated:	May 29, 2009
ClinicalTrials.gov Identifier:	NCT00083083 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

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

Additional relevant MeSH terms:

Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Vinblastine
Docetaxel
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type

Mitosis Modulators
Antimitotic Agents
Carboplatin
Pharmacologic Actions
Carcinoma
Neoplasms
Vinorelbine
Radiation-Sensitizing Agents
Paclitaxel
Lung Diseases
Tubulin Modulators
Carcinoma, Non-Small-Cell Lung
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 27, 2009