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

Sponsor

American College of Radiology Imaging Network (Other)

Overall Status

Unknown status

CT.gov ID

NCT00083083

Collaborator

National Cancer Institute (NCI) (NIH), Radiation Therapy Oncology Group (Other)

250

Enrollment

Locations

5.1

Patients Per Site

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Drug: carboplatin Drug: cisplatin Drug: docetaxel Drug: etoposide Drug: paclitaxel Drug: vinblastine sulfate Drug: vinorelbine tartrate Genetic: gene expression analysis Procedure: positron emission tomography Radiation: fludeoxyglucose F 18 Radiation: radiation therapy	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

250 participants

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Mar 1, 2005

Anticipated Primary Completion Date :

Jun 1, 2006

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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 []
Reliability between PET scan-defined response to therapy measurements []
Correlation of Ki-67 expression with peak and max pre-treatment SUV []
Association between Ki-67 expression and overall survival at 2 years []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

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