Radiation Therapy Combined With Paclitaxel and Carboplatin in Treating Patients With Stage III Non-Small Cell Lung Cancer
NCT ID: NCT00023673
Last Updated: 2017-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
63 participants
INTERVENTIONAL
2001-07-31
2013-11-30
Brief Summary
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PURPOSE: This phase I/II trial is studying the effectiveness of radiation therapy combined with paclitaxel and carboplatin in treating patients who have stage III non-small cell lung cancer.
Detailed Description
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* Determine the maximum tolerated dose of 3-dimensional conformal radiotherapy when administered concurrently with paclitaxel and carboplatin in patients with inoperable stage IIIA or IIIB non-small cell lung cancer. (Phase I) (Closed to accrual as of 01/13/04.)
* Determine the 12-month survival rate in patients treated with this regimen. (Phase II) (Closed to accrual as of 11/27/07.)
* Determine the toxicity of this regimen in these patients.
* Determine the partial organ tolerance doses for the lung and esophagus in patients treated with this regimen.
* Determine the complete response rate in patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of 3-dimensional conformal radiotherapy.
* Phase I (closed to accrual as of 01/13/04): Patients undergo 3-dimensional conformal radiotherapy once daily five days a week for 7-8 weeks. Patients also receive concurrent chemotherapy comprising paclitaxel IV over 1 hour followed by carboplatin IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43.
Cohorts of 7-9 patients receive de-escalating doses of 3-dimensional conformal radiotherapy until the maximum tolerated dose (MTD) is determined when given in combination with chemotherapy. The MTD is defined as the highest dose at which no more than 1 patient experiences dose-limiting toxicity.
* Phase II: Additional patients are accrued and treated as above at the MTD. At least 3 weeks after completing radiotherapy, patients may receive additional chemotherapy comprising paclitaxel IV over 3 hours once and carboplatin IV over 30 minutes once. Treatment with paclitaxel and carboplatin may repeat every 3 weeks for up to 2 courses.
Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3-5 years, and then annually thereafter.
PROJECTED ACCRUAL: A maximum of 73 patients (up to 27 for phase I \[closed to accrual as of 10/28/04\] and 46 for phase II) will be accrued for this study within 1-1.5 years.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Phase I: 75.25 Gy/36 fx + chemotherapy
Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
carboplatin
paclitaxel
three-dimensional conformal radiation therapy
Phase I: 74 Gy/37 fx + chemotherapy
Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
carboplatin
paclitaxel
three-dimensional conformal radiation therapy
Phase I: 70 Gy/35 fx + chemotherapy
Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
carboplatin
paclitaxel
three-dimensional conformal radiation therapy
Phase II: 74 Gy/37 fx + chemotherapy
Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
carboplatin
paclitaxel
three-dimensional conformal radiation therapy
Interventions
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carboplatin
paclitaxel
three-dimensional conformal radiation therapy
Eligibility Criteria
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Inclusion Criteria
Age:
* Not specified
Performance status:
* Zubrod 0-1
Life expectancy:
* Not specified
Hematopoietic:
* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.5 mg/dL
* Aspartate aminotransferase (AST) less than 2 times upper limit of normal
Renal:
* Creatinine no greater than 2.0 mg/dL
Pulmonary:
* Forced expiratory volume (FEV)\_1 at least 1.0 L
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No weight loss greater than 5% in the past 6 months
* No other malignancy within the past year except nonmelanoma skin cancer
* Completed 3D plan with total lung V20 \</= 30% mean esophageal dose \</= 34 Gy and esophageal V55 \</= 30%
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No prior biologic response modifiers for current lung cancer
* At least 5 years since prior biologic response modifiers
Chemotherapy:
* No prior chemotherapy for current lung cancer
* At least 5 years since prior chemotherapy
Endocrine therapy:
* Not specified
Radiotherapy:
* See Disease Characteristics
* No prior radiotherapy to the thorax
Surgery:
* No prior complete tumor resection
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Radiation Therapy Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Jeffrey Bradley, MD
Role: STUDY_CHAIR
Mallinckrodt Institute of Radiology at Washington University Medical Center
Locations
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Mobile Infirmary Medical Center
Mobile, Alabama, United States
Arizona Oncology Services Foundation
Phoenix, Arizona, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Providence Holy Cross Cancer Center
Mission Hills, California, United States
University of California Davis Cancer Center
Sacramento, California, United States
Bay Medical
Panama City, Florida, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton, Illinois, United States
Alexian Brothers Radiation Oncology
Elk Grove Village, Illinois, United States
Good Samaritan Regional Health Center
Mount Vernon, Illinois, United States
Oncology Center at Saint Margaret Mercy Healthcare Center
Hammond, Indiana, United States
Cancer Center at Ball Memorial Hospital
Muncie, Indiana, United States
Regional Cancer Center at Singing River Hospital
Pascagoula, Mississippi, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Cape Girardeau, Missouri, United States
Cancer Institute of Cape Girardeau, LLC
Cape Girardeau, Missouri, United States
Saint Francis Medical Center
Cape Girardeau, Missouri, United States
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
CCOP - St. Louis-Cape Girardeau
St Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
St Louis, Missouri, United States
Ocean Medical Center at Meridian Health
Brick, New Jersey, United States
J. Phillip Citta Regional Cancer Center at Community Medical Center
Toms River, New Jersey, United States
Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Vineland, New Jersey, United States
CCOP - Hematology-Oncology Associates of Central New York
East Syracuse, New York, United States
High Point Regional Hospital
High Point, North Carolina, United States
Summa Center for Cancer Care at Akron City Hospital
Akron, Ohio, United States
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Cancer Treatment Center
Wooster, Ohio, United States
Three Rivers Community Hospital
Grants Pass, Oregon, United States
Dubs Cancer Center at Rogue Valley Medical Center
Medford, Oregon, United States
Providence Cancer Center at PMCC
Medford, Oregon, United States
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, United States
Rapid City Regional Hospital
Rapid City, South Dakota, United States
University of Texas Medical Branch
Galveston, Texas, United States
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States
Schiffler Cancer Center at Wheeling Hospital
Wheeling, West Virginia, United States
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States
Medical College of Wisconsin Cancer Center
Milwaukee, Wisconsin, United States
Veterans Affairs Medical Center - Milwaukee
Milwaukee, Wisconsin, United States
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Countries
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References
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Bradley JD, Bae K, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. Primary analysis of the phase II component of a phase I/II dose intensification study using three-dimensional conformal radiation therapy and concurrent chemotherapy for patients with inoperable non-small-cell lung cancer: RTOG 0117. J Clin Oncol. 2010 May 10;28(14):2475-80. doi: 10.1200/JCO.2009.27.1205. Epub 2010 Apr 5.
Bradley JD, Moughan J, Graham MV, Byhardt R, Govindan R, Fowler J, Purdy JA, Michalski JM, Gore E, Choy H. A phase I/II radiation dose escalation study with concurrent chemotherapy for patients with inoperable stages I to III non-small-cell lung cancer: phase I results of RTOG 0117. Int J Radiat Oncol Biol Phys. 2010 Jun 1;77(2):367-72. doi: 10.1016/j.ijrobp.2009.04.029.
Bradley JD, Graham M, Suzanne S, et al.: Phase I results of RTOG L-0117: a phase I/II dose intensification study using 3DCRT and concurrent chemotherapy for patients with inoperable NSCLC. [Abstract] J Clin Oncol 23 (Suppl 16): A-7063, 636s, 2005.
Other Identifiers
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CDR0000068850
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-2012-02401
Identifier Type: REGISTRY
Identifier Source: secondary_id
RTOG L-0117
Identifier Type: -
Identifier Source: org_study_id