- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00033553
Combination Chemotherapy and Computer-Planned Radiation Therapy in Treating Patients With Unresectable Stage III Non-Small Cell Lung Cancer
Induction/Concurrent Chemotherapy and Dose-Escalated Three Dimensional Thoracic Radiation for Patients With Stage III Non Small Cell Lung Cancer: A Randomized Phase II Study
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Computer systems that allow doctors to create a 3-dimensional picture of the tumor to plan treatment may result in more effective radiation therapy. It is not yet known which chemotherapy and/or radiation therapy regimen is more effective in treating non-small cell lung cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of different combination chemotherapy regimens and 3-dimensional radiation therapy in treating patients who have unresectable stage III non-small cell lung cancer.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
OBJECTIVES:
- Compare the overall response rate, failure-free survival, and survival of patients with inoperable stage IIIA or IIIB non-small cell lung cancer treated with paclitaxel and carboplatin with concurrent 3-dimensional conformal radiotherapy (3-D XRT) vs gemcitabine and carboplatin with concurrent 3-D XRT.
- Compare the toxicity of these regimens in these patients.
- Compare the pattern of failure (locoregional vs distant failure) in patients treated with these regimens.
- Determine the feasibility of delivering 3-D XRT to patients in this multicenter study.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.
- Arm I: Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes once weekly and 3-dimensional conformal radiotherapy (3-D XRT) once daily 5 days a week. Treatment repeats weekly for 7 courses.
- Arm II: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses. Patients then receive gemcitabine IV over 30 minutes twice weekly and 3-D XRT as in arm I. Treatment repeats weekly for 7 courses.
In both arms, treatment continues in the absence of disease progression.
Patients are followed every 2 months for 2 years, every 4 months for 2 years, and then annually for 2 years.
PROJECTED ACCRUAL: A total of 82 patients (41 per treatment arm) will be accrued for this study within 9 months.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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Alabama
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Anniston, Alabama, Forente stater, 36207
- Northeast Alabama Regional Medical Center
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California
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La Jolla, California, Forente stater, 92093-0658
- Rebecca and John Moores UCSD Cancer Center
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Los Angeles, California, Forente stater, 90048
- Cedars-Sinai Comprehensive Cancer Center at Cedars-Sinai Medical Center
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San Diego, California, Forente stater, 92161
- Veterans Affairs Medical Center - San Diego
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San Diego, California, Forente stater, 92134-3202
- Naval Medical Center - San Diego
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San Francisco, California, Forente stater, 94115
- UCSF Comprehensive Cancer Center
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San Francisco, California, Forente stater, 94121
- Veterans Affairs Medical Center - San Francisco
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Delaware
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Newark, Delaware, Forente stater, 19713
- CCOP - Christiana Care Health Services
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District of Columbia
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Washington, District of Columbia, Forente stater, 20422
- Veterans Affairs Medical Center - Washington, DC
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Washington, District of Columbia, Forente stater, 20007
- Lombardi Cancer Center at Georgetown University Medical Center
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Washington, District of Columbia, Forente stater, 20307-5001
- Walter Reed Army Medical Center
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Florida
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Fort Lauderdale, Florida, Forente stater, 33316
- Broward General Medical Center
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Hollywood, Florida, Forente stater, 33021
- Memorial Regional Cancer Center at Memorial Regional Hospital
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Miami Beach, Florida, Forente stater, 33140
- CCOP - Mount Sinai Medical Center
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Orlando, Florida, Forente stater, 32804
- Florida Hospital Cancer Institute
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Illinois
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Chicago, Illinois, Forente stater, 60612
- Veterans Affairs Medical Center - Chicago (Westside Hospital)
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Chicago, Illinois, Forente stater, 60637-1470
- University of Chicago Cancer Research Center
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Chicago, Illinois, Forente stater, 60640
- Louis A. Weiss Memorial Hospital
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Peoria, Illinois, Forente stater, 61615-7828
- CCOP - Illinois Oncology Research Association
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River Forest, Illinois, Forente stater, 60305
- West Suburban Center for Cancer Care
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Indiana
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Fort Wayne, Indiana, Forente stater, 46885-5099
- Fort Wayne Medical Oncology and Hematology, Incorporated
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South Bend, Indiana, Forente stater, 46601
- CCOP - Northern Indiana CR Consortium
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Iowa
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Iowa City, Iowa, Forente stater, 52242-1009
- Holden Comprehensive Cancer Center at University of Iowa
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Kentucky
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Louisville, Kentucky, Forente stater, 40207
- Baptist Hospital East - Louisville
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
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Worcester, Massachusetts, Forente stater, 01655
- UMASS Memorial Cancer Center - University Campus
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Michigan
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Saint Joseph, Michigan, Forente stater, 49085
- Lakeland Cancer Care Center at Lakeland Hospital - St. Joseph
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55417
- Veterans Affairs Medical Center - Minneapolis
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota Cancer Center
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Missouri
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Columbia, Missouri, Forente stater, 65201
- Veterans Affairs Medical Center - Columbia (Truman Memorial)
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Columbia, Missouri, Forente stater, 65203
- Ellis Fischel Cancer Center at University of Missouri - Columbia
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Kansas City, Missouri, Forente stater, 64131
- CCOP - Kansas City
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Saint Louis, Missouri, Forente stater, 63131
- Missouri Baptist Cancer Center
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Saint Louis, Missouri, Forente stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-7680
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
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Nevada
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Las Vegas, Nevada, Forente stater, 89106
- CCOP - Southern Nevada Cancer Research Foundation
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Las Vegas, Nevada, Forente stater, 89106
- Veterans Affairs Medical Center - Las Vegas
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New Hampshire
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Hooksett, New Hampshire, Forente stater, 03106
- New Hampshire Oncology-Hematology, PA - Hooksett
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Lebanon, New Hampshire, Forente stater, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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New Jersey
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Camden, New Jersey, Forente stater, 08103
- Cancer Institute of New Jersey at the Cooper University Hospital
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New York
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Buffalo, New York, Forente stater, 14263-0001
- Roswell Park Cancer Institute
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Buffalo, New York, Forente stater, 14215
- Veterans Affairs Medical Center - Buffalo
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East Syracuse, New York, Forente stater, 13057
- CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.
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Elmhurst, New York, Forente stater, 11373
- Elmhurst Hospital Center
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Jamaica, New York, Forente stater, 11432
- Queens Cancer Center of Queens Hospital
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Manhasset, New York, Forente stater, 11030
- CCOP - North Shore University Hospital
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Manhasset, New York, Forente stater, 11030
- North Shore University Hospital
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New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
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New York, New York, Forente stater, 10021
- New York Weill Cornell Cancer Center at Cornell University
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New York, New York, Forente stater, 10029
- Mount Sinai Medical Center
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Syracuse, New York, Forente stater, 13210
- Veterans Affairs Medical Center - Syracuse
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Syracuse, New York, Forente stater, 13210
- SUNY Upstate Medical University Hospital
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North Carolina
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Asheville, North Carolina, Forente stater, 28805
- Veterans Affairs Medical Center - Asheville
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
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Concord, North Carolina, Forente stater, 28025
- NorthEast Oncology Associates - Concord
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Durham, North Carolina, Forente stater, 27705
- Veterans Affairs Medical Center - Durham
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Durham, North Carolina, Forente stater, 27710
- Duke Comprehensive Cancer Center
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Fayetteville, North Carolina, Forente stater, 28302-2000
- Cape Fear Valley Health System
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Goldsboro, North Carolina, Forente stater, 27534-9479
- CCOP - Southeast Cancer Control Consortium
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Kinston, North Carolina, Forente stater, 28503-1678
- Lenoir Memorial Cancer Center
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Pinehurst, North Carolina, Forente stater, 28374
- Comprehensive Cancer Center at Moore Regional Hospital
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Wilmington, North Carolina, Forente stater, 28402-9025
- Zimmer Cancer Center at New Hanover Regional Medical Center
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Winston-Salem, North Carolina, Forente stater, 27157-1082
- Comprehensive Cancer Center at Wake Forest University
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Ohio
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Columbus, Ohio, Forente stater, 43210-1240
- Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73104
- Oklahoma University Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15224
- Western Pennsylvania Hospital
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Rhode Island
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Providence, Rhode Island, Forente stater, 02906
- Lifespan: The Miriam Hospital
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Texas
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Dallas, Texas, Forente stater, 75219
- Veterans Affairs Medical Center - Dallas
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Vermont
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Burlington, Vermont, Forente stater, 05401-3498
- Vermont Cancer Center at University of Vermont
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Virginia
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Charlottesville, Virginia, Forente stater, 22902
- Martha Jefferson Hospital
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Norfolk, Virginia, Forente stater, 23502
- Virginia Oncology Associates - Norfolk
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Richmond, Virginia, Forente stater, 23298-0037
- MBCCOP - Massey Cancer Center
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Roanoke, Virginia, Forente stater, 24014
- Oncology and Hematology Associates of Southwest Virginia, Incorporated - Roanoke
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West Virginia
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Huntington, West Virginia, Forente stater, 25701
- St. Mary's Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)
- Squamous cell carcinoma
- Adenocarcinoma, including bronchoalveolar cell carcinoma
- Large cell anaplastic carcinoma, including giant and clear cell carcinoma
- Inoperable stage IIIA or IIIB disease
No direct invasion of vertebral body
- Tumors adjacent to a vertebral body without bone invasion allowed if all gross disease can be encompassed in radiotherapy boost field
- Contralateral mediastinal disease (N3) allowed if all gross disease can be encompassed in radiotherapy boost field
- No scalene, supraclavicular, or contralateral hilar node involvement
Transudate, cytologically negative, non-bloody pleural effusion allowed if it can be encompassed in radiotherapy field
- No exudative, bloody, or cytologically malignant pleural effusion
- Evidence of pleural effusion by chest CT scan but not chest x-ray that is too small to tap allowed
At least 1 unidimensionally measurable lesion
- At least 20 mm by conventional techniques OR
- At least 10 mm by spiral CT scan
The following are not considered measurable disease:
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions in a previously irradiated field
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-1
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,000/mm3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- AST less than 2 times upper limit of normal
Renal:
- Creatinine clearance 20-130 mL/min for females
- Creatinine clearance 20-150 mL/min for males
Pulmonary:
- FEV1 at least 1.2 L
Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other currently active malignancy (defined as completed prior therapy and considered to be at less than 30% risk of relapse) except non-melanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for NSCLC
- No other concurrent chemotherapy
Endocrine therapy:
- No concurrent hormonal therapy except steroids for adrenal failure or septic shock, hormones for non-disease-related conditions (e.g., insulin for diabetes), or glucocorticosteroids as antiemetics
Radiotherapy:
- See Disease Characteristics
- No prior radiotherapy for NSCLC
Surgery:
- At least 2 weeks since prior exploratory thoracotomy
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Paclitaxel + Carboplatin
Paclitaxel and carboplatin induction (2 cycles)followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
225 mg/sq m IV over 3 hrs q 21 days for 2 cycles, then 45 mg/sq m IV over 1 hr q wk for 7 wks
3-D XRT 7400 cGy total after induction (during cycles 3-9)
|
Eksperimentell: Gemcitabine + Carboplatin
Gemcitabine and carboplatin induction (2cycles) followed by chemotherapy with the addition of radiotherapy for 7 cycles
|
Arm A: AUC=6 IV over 30 min for 2 cycles then AUC=2 IV over 30 min q wk for 7 wks Arm B: AUC=5 IV over 30 min for 2 cycles
3-D XRT 7400 cGy total after induction (during cycles 3-9)
1000 mg/sq m IV over 30 min days 1 & 8 repeat q 21 days for 2 cycles; then 35 mg/sq m IV over 30 min 2X wk for 7 wks
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Response
Tidsramme: 18 months post treatment
|
Response is assessed as failure free survival
|
18 months post treatment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Survival
Tidsramme: 6 years post treatment
|
6 years post treatment
|
|
Toxicity
Tidsramme: 13 weeks
|
Toxicity will be assessed during treatment
|
13 weeks
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Studiestol: Arthur William Blackstock, MD, Wake Forest University Health Sciences
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Socinski MA, Blackstock AW, Bogart JA, Wang X, Munley M, Rosenman J, Gu L, Masters GA, Ungaro P, Sleeper A, Green M, Miller AA, Vokes EE. Randomized phase II trial of induction chemotherapy followed by concurrent chemotherapy and dose-escalated thoracic conformal radiotherapy (74 Gy) in stage III non-small-cell lung cancer: CALGB 30105. J Clin Oncol. 2008 May 20;26(15):2457-63. doi: 10.1200/JCO.2007.14.7371.
- Blackstock AW, Socinski MA, Bogart J, et al.: Induction (Ind) plus concurrent (Con) chemotherapy with high-dose (74 Gy) 3-dimensional (3-D) thoracic radiotherapy (TRT) in stage III non-small cell lung cancer (NSCLC): preliminary report of Cancer and Leukemia Group B (CALGB) 30105. [Abstract] J Clin Oncol 24 (Suppl 18): A-7042, 374s, 2006.
- Blackstock AW, Socinski MA, Gu L, et al.: Initial pulmonary toxicity evaluation of chemoradiotherapy (CRT) utilizing 74 Gy 3-dimensional (3-D) thoracic radiation in stage III non-small cell lung cancer (NSCLC): a Cancer and Leukemia Group B (CALGB) randomized phase II trial. [Abstract] J Clin Oncol 23 (Suppl 16): A-7060, 635s, 2005.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Neoplasmer
- Lungesykdommer
- Neoplasmer etter nettsted
- Neoplasmer i luftveiene
- Thoracale neoplasmer
- Karsinom, bronkogent
- Bronkiale neoplasmer
- Lungeneoplasmer
- Karsinom, ikke-småcellet lunge
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-infeksjonsmidler
- Antivirale midler
- Enzymhemmere
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Gemcitabin
- Karboplatin
- Paklitaksel
Andre studie-ID-numre
- CALGB-30105
- U10CA031946 (U.S. NIH-stipend/kontrakt)
- CDR0000069300 (Registeridentifikator: NCI Physician Data Query)
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