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

Lung Cancer Clinical Trial

Official title:

Positron Emission Tomography Pre- and Post-treatment Assessment For Locally Advanced Non-Small Cell Lung Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00083083
• Other study ID #: CDR0000362061
• Secondary ID: ACRIN-6668RTOG-0
• Status: Active, not recruiting
• Phase: Phase 2
• First received: May 14, 2004
• Last updated: February 26, 2011
• Start date: March 2005

Study information

• Verified date: October 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00194389

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Neoplasms

Intervention

Drug:
• carboplatin

• cisplatin

• docetaxel

• etoposide

• paclitaxel

• vinblastine sulfate

• vinorelbine tartrate

Genetic:
• gene expression analysis

Procedure:
• positron emission tomography

Radiation:
• fludeoxyglucose F 18

• radiation therapy

Locations

Country	Name	City	State
Canada	Tom Baker Cancer Centre - Calgary	Calgary	Alberta
Canada	Grand River Regional Cancer Centre at Grand River Hospital	Kitchner	Ontario
Korea, Republic of	National Cancer Center - Korea	Goyang
United States	McDowell Cancer Center at Akron General Medical Center	Akron	Ohio
United States	Saint John's Cancer Center at Saint John's Medical Center	Anderson	Indiana
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Dana-Farber Partners Cancer Care	Boston	Massachusetts
United States	Bethesda Comprehensive Cancer Care Center at Bethesda Memorial Hospital	Boynton Beach	Florida
United States	Hollings Cancer Center at Medical University of South Carolina	Charleston	South Carolina
United States	Rush Cancer Institute at Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Cancer Center at Fairview Hospital	Cleveland	Ohio
United States	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	North Broward Medical Center	Dearfield Beach	Florida
United States	Josephine Ford Cancer Center at Henry Ford Hospital	Detroit	Michigan
United States	Center for Cancer Care at Goshen General Hospital	Goshen	Indiana
United States	M. D. Anderson Cancer Center at University of Texas	Houston	Texas
United States	Integrated Community Oncology Network at Baptist Cancer Institute	Jacksonville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	USC/Norris Comprehensive Cancer Center and Hospital	Los Angeles	California
United States	University of Wisconsin Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Hospital of Saint Raphael	New Haven	Connecticut
United States	Oklahoma University Cancer Institute	Oklahoma City	Oklahoma
United States	Albert Einstein Cancer Center	Philadelphia	Pennsylvania
United States	Fox Chase Cancer Center - Philadelphia	Philadelphia	Pennsylvania
United States	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia	Philadelphia	Pennsylvania
United States	UPMC Cancer Centers	Pittsburgh	Pennsylvania
United States	Knight Cancer Institute at Oregon Health and Science University	Portland	Oregon
United States	Brown University School of Medicine	Providence	Rhode Island
United States	Roger Williams Medical Center	Providence	Rhode Island
United States	Renown Institute for Cancer at Renown Regional Medical Center	Reno	Nevada
United States	Bon Secours Cancer Institute at St. Mary's Hospital	Richmond	Virginia
United States	William Beaumont Hospital - Royal Oak Campus	Royal Oak	Michigan
United States	Radiological Associates of Sacramento Medical Group at Sutter Cancer Center	Sacramento	California
United States	Huntsman Cancer Institute at University of Utah	Salt Lake City	Utah
United States	Scottsdale Medical Imaging, Limited	Scottsdale	Arizona
United States	CCOP - Northern Indiana CR Consortium	South Bend	Indiana
United States	South Shore Hospital	South Weymouth	Massachusetts
United States	Gibbs Regional Cancer Center at Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Mallinckrodt Institute of Radiology at Washington University Medical Center	St. Louis	Missouri
United States	Tallahassee Memorial Hospital	Tallahassee	Florida
United States	Sister Patricia Lynch Regional Cancer Center at Holy Name Hospital	Teaneck	New Jersey
United States	J. Phillip Citta Regional Cancer Center at Community Medical Center	Toms River	New Jersey
United States	Waukesha Memorial Hospital Regional Cancer Center	Waukesha	Wisconsin
United States	Lankenau Cancer Center at Lankenau Hospital	Wynnewood	Pennsylvania

Sponsors (3)

Lead Sponsor	Collaborator
American College of Radiology Imaging Network	National Cancer Institute (NCI), Radiation Therapy Oncology Group

Countries where clinical trial is conducted

United States,  Canada,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship of survival to post-treatment peak standardized uptake value (SUV) as determined by the imaging institution			No
Secondary	Relationship of survival to post-treatment max SUV as determined by the imaging institute			No
Secondary	Relationship of local control to post-treatment peak and max SUV as determined by the imaging institution			No
Secondary	Relationship of survival and of local control to pre-treatment peak and max SUV as determined by the imaging institution			No
Secondary	Reliability between peak and max SUV measurements both pre- and post-treatment			No
Secondary	Proportion of participants who are either upstaged or downstaged by positron emission tomography scan			No
Secondary	Reliability between PET scan-defined response to therapy measurements			No
Secondary	Correlation of Ki-67 expression with peak and max pre-treatment SUV			No
Secondary	Association between Ki-67 expression and overall survival at 2 years			No