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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Mitchell Machtay, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Kimmel Cancer Center (KCC)

Authority:

United States: Federal Government

Study ID:

CDR0000362061

NCT ID:

NCT00083083

Start Date:

March 2005

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage II non-small cell lung cancer
  • stage IIIA non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Roger Williams Medical CenterProvidence, Rhode Island  02908-4735
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Waukesha Memorial Hospital Regional Cancer CenterWaukesha, Wisconsin  53188
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
Tallahassee Memorial HospitalTallahassee, Florida  32308
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Knight Cancer Institute at Oregon Health and Science UniversityPortland, Oregon  97239-3098
M. D. Anderson Cancer Center at University of TexasHouston, Texas  77030-4009
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Bon Secours Cancer Institute at St. Mary's HospitalRichmond, Virginia  23226
Lurleen Wallace Comprehensive Cancer at University of Alabama - BirminghamBirmingham, Alabama  35294
Hospital of Saint RaphaelNew Haven, Connecticut  06511
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612
Center for Cancer Care at Goshen General HospitalGoshen, Indiana  46526
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
South Shore HospitalSouth Weymouth, Massachusetts  02190
Mallinckrodt Institute of Radiology at Washington University Medical CenterSt. Louis, Missouri  63110
Brown University School of MedicineProvidence, Rhode Island  02905
Saint John's Cancer Center at Saint John's Medical CenterAnderson, Indiana  46016
Renown Institute for Cancer at Renown Regional Medical CenterReno, Nevada  89502
North Broward Medical CenterDearfield Beach, Florida  33064-3596
Scottsdale Medical Imaging, LimitedScottsdale, Arizona  85262
Radiological Associates of Sacramento Medical Group at Sutter Cancer CenterSacramento, California  95816
Bethesda Comprehensive Cancer Care Center at Bethesda Memorial HospitalBoynton Beach, Florida  33435
Integrated Community Oncology Network at Baptist Cancer InstituteJacksonville, Florida  32207
Dana-Farber Partners Cancer CareBoston, Massachusetts  02129
Sister Patricia Lynch Regional Cancer Center at Holy Name HospitalTeaneck, New Jersey  07666