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A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Adjuvant Chemotherapy in Patients With Early Stage Non-Small Cell Lung Cancer Associated With Banking of Frozen Tumor Specimens and Collection of Gene Expression Profile Data


OBJECTIVES:

Primary

- To determine the potential overall survival benefit of adjuvant chemotherapy in
patients with early stage non-small cell lung cancer (NSCLC) randomized to chemotherapy
compared to those randomized to the present standard of care (observation).

- To collect and process high-quality fresh frozen lung cancer tumor tissue for gene
expression array generation from multiple institutions.

Secondary

- To evaluate selected genomic-based lung cancer prognostic models using data from the
patients randomized to observation after resection.

- To characterize the rate of chemotherapy toxicity for the different chemotherapy
treatment regimens.

- To assess quality of life (QOL) in early stage patients periodically after resection
for NSCLC.

- To examine the impact of chemotherapy on QOL for patients receiving chemotherapy, as
compared to patients in the observation arm.

OUTLINE: This is a multicenter study. Patients are stratified according to pathologic stage
(I vs II) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment
arms within 12 weeks after surgery.

All patients undergo complete resection of disease (i.e., lobectomy, sleeve lobectomy,
bi-lobectomy, or pneumonectomy, but not segmentectomy or wedge resection).

- Arm I: Patients receive 1 of 3 chemotherapy regimens. Treatment repeats every 21 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.

- Regimen 1: Patients receive vinorelbine ditartrate IV over 10 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 2: Patients receive docetaxel IV over 60 minutes and cisplatin IV over 60
minutes on day 1.

- Regimen 3: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1
and 8 and cisplatin IV over 60 minutes on day 1.

- Regimen 4: Patients receive pemetrexed disodium IV over 10 minutes and cisplatin
IV over 60 minutes on day 1.

- Arm II: Patients receive standard care (observation). Tissue obtained at surgery is
examined by RNA microarray analysis. A Lung Metagene Score (LMS) is determined for each
patient and correlated with survival and response.

After completion of study treatment, patients are followed every 6 months for 5 years and
then once a year for 7 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed non-small cell lung cancer

- Any variant allowed (e.g., pure or mixed bronchioloalveolar carcinoma or
adenosquamous cell carcinoma)

- Primary tumor must be T1a, T1b, T2a, or T2b by AJCC 7.0

- No status

- Tumor measuring ≥ 2.0 cm but ≤ 7.0 cm in diameter by CT scan

- The mass must have a source document to verify tumor size in the greatest
dimension, which includes a CT scan report, a clinic note from the enrolling
physician, and/or a printed image with caliper measurements on the lung mass

- Node-negative disease

- Evidence of hilar or mediastinal node involvement by chest CT scan (> 1 cm
diameter) must be assessed with mediastinoscopy, endo-esophageal ultrasound with
biopsy, endo-bronchial ultrasound, bronchoscopy, or mediastinal nodal sampling
before or at time of thoracotomy

- No locally advanced or metastatic disease

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Granulocytes ≥ 1,500/μL

- Platelet count ≥ 100,000/μL

- Bilirubin ≤ 1.5 mg/dL

- AST < 1.5 times upper limit of normal (ULN)

- Serum creatinine ≤ 1.5 times ULN

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No history of prior or concurrent malignancy, except curatively treated carcinoma in
situ of the cervix, basal cell or squamous cell carcinoma of the skin, surgically
treated in situ carcinoma of the breast, or other cancer for which the patient has
been disease-free for 3 years

PRIOR CONCURRENT THERAPY:

- More than 3 years since prior cytotoxic or anticancer treatment

- No concurrent treatment with hormones or other chemotherapeutic agents, except
steroids given for adrenal failure, hormone administered for nondisease-related
conditions (e.g., insulin for diabetes), or intermittent use of dexamethasone as an
antiemetic

- No concurrent thoracic radiotherapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:

No

Principal Investigator

David H. Harpole, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute

Authority:

United States: Federal Government

Study ID:

CDR0000636895

NCT ID:

NCT00863512

Start Date:

March 2009

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IA non-small cell lung cancer
  • stage IB non-small cell lung cancer
  • stage IIA non-small cell lung cancer
  • adenocarcinoma of the lung
  • adenosquamous cell lung cancer
  • bronchoalveolar cell lung cancer
  • large cell lung cancer
  • squamous cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
Medical City Dallas HospitalDallas, Texas  75230
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Mercy Cancer Center at Mercy Medical CenterCanton, Ohio  44708
Natalie Warren Bryant Cancer Center at St. Francis HospitalTulsa, Oklahoma  74136
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
MultiCare Regional Cancer Center at Tacoma General HospitalTacoma, Washington  98405
CCOP - NorthwestTacoma, Washington  98405-0986
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
Maine Center for Cancer Medicine and Blood Disorders - ScarboroughScarborough, Maine  04074
Central Baptist HospitalLexington, Kentucky  40503
Alvin and Lois Lapidus Cancer Institute at Sinai HospitalBaltimore, Maryland  21215
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Green Bay Oncology, Limited - EscanabaEscanaba, Michigan  49431
Dickinson County Healthcare SystemIron Mountain, Michigan  49801
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Green Bay Oncology, Limited - Oconto FallsOconto Falls, Wisconsin  54154
Green Bay Oncology, Limited - Sturgeon BaySturgeon Bay, Wisconsin  54235
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Memorial Cancer Institute at Memorial Regional HospitalHollywood, Florida  33021
Lucille P. Markey Cancer Center at University of KentuckyLexington, Kentucky  40536-0093
Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Methodist Estabrook Cancer CenterOmaha, Nebraska  68114-4199
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Helen and Harry Gray Cancer Center at Hartford HospitalHartford, Connecticut  06102-5037
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
UPMC Cancer CentersPittsburgh, Pennsylvania  15232
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Holy Family Memorial Medical Center Cancer Care CenterManitowoc, Wisconsin  54221-1450
St. Francis HospitalFederal Way, Washington  98003
St. Clare HospitalLakewood, Washington  98499-0998
Providence St. Peter Hospital Regional Cancer CenterOlympia, Washington  98506
Good Samaritan Cancer CenterPuyallup, Washington  98371
Allenmore HospitalTacoma, Washington  98411-0414
Lancaster General HospitalLancaster, Pennsylvania  17604-3555
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Allegheny Cancer Center at Allegheny General HospitalPittsburgh, Pennsylvania  15212
UAB Comprehensive Cancer CenterBirmingham, Alabama  35294
Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Michiana Hematology Oncology PC - NilesNiles, Michigan  49120
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at Ohio State University Comprehensive Cancer CenterColumbus, Ohio  43210-1240
St. Luke's Cancer Network at St. Luke's HospitalBethlehem, Pennsylvania  18015
Providence Centralia HospitalCentralia, Washington  98531-9027
Franciscan Cancer Center at St. Joseph Medical CenterTacoma, Washington  98405-3004
Robert and Beverly Lewis Family Cancer Care Center at Pomona Valley Hospital Medical CenterPomona, California  91767
Easton Regional Cancer Center at Easton HospitalEaston, Pennsylvania  18042
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Kinston Medical SpecialistsKinston, North Carolina  28501
Glendale Memorial Hospital Comprehensive Cancer CenterGlendale, California  91204
Resurrection Medical CenterChicago, Illinois  60631
Newton-Wellesley HospitalNewton, Massachusetts  02462
Lynchburg Hematology-Oncology ClinicLynchburg, Virginia  24501
New Hampshire Oncology - Hematology, PA at Payson Center for Cancer CareConcord, New Hampshire  03301
New Hampshire Oncology - Hematology, PA - HooksettHooksett, New Hampshire  03106
Faxton Regional Cancer CenterUtica, New York  13502
Fountain Valley, California  92708
Regional Medical CenterAnniston, Alabama  36202
Jameson Memorial Hospital - North CampusNew Castle, Pennsylvania  16105
Cancer Institute at St. Joseph Medical CenterTowson, Maryland  21204
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
St. Nicholas HospitalSheboygan, Wisconsin  53081
Saint Francis Hospital Cancer CenterPoughkeepsie, New York  12601