Phase I/II Study Of Concurrent Chemotherapy And Escalating Doses Of Radiotherapy (RT) For Unresectable Non-Small Cell Lung Cancer (NSCLC) Using A New RT Paradigm
- Determine the maximum tolerated dose of radiotherapy in combination with carboplatin
and paclitaxel in patients with unresectable non-small cell lung cancer.
- Determine the 2-year survival of patients treated with this regimen.
- Determine the progression-free local control rate in patients treated this regimen.
- Determine the tolerability of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: This is a multicenter, dose-escalation study of radiotherapy.
Patients undergo radiotherapy* once daily 5 days a week for 7 weeks and 2 days (a total of
37 fractions). Patients concurrently receive paclitaxel IV over 3 hours and carboplatin IV
over 30 minutes once weekly for 7 weeks. Treatment continutes in the absence of disease
progression or unacceptable toxicity.
NOTE: *No prophylactic nodal radiotherapy is administered
Cohorts of 3-6 patients receive escalating doses of radiotherapy until the maximum tolerated
dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2
of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 12
additional patients are treated at that dose level in the phase II portion of the study.
Beginning 3 weeks after completion of radiotherapy, patients receive paclitaxel and
carboplatin as above. Treatment repeats every 21 days for 3 courses in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, once during the last week of radiotherapy, and then
every 3 months for 2 years.
Patients are followed at 3 weeks, every 3 months for 21 months, and then every 6 months for
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Primary Purpose: Treatment
Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)
Steven E. Schild, MD
United States: Federal Government
|Mayo Clinic Scottsdale||Scottsdale, Arizona 85259|
|Mayo Clinic - Jacksonville||Jacksonville, Florida 32224|
|Mayo Clinic Cancer Center||Rochester, Minnesota 55905|
|CCOP - Missouri Valley Cancer Consortium||Omaha, Nebraska 68131|
|CCOP - Iowa Oncology Research Association||Des Moines, Iowa 50309-1016|
|Mercy Medical Center - Sioux City||Sioux City, Iowa 51104|
|Siouxland Hematology-Oncology Associates, LLP||Sioux City, Iowa 51101|
|St. Luke's Regional Medical Center||Sioux City, Iowa 51104|
|MeritCare Bemidji||Bemidji, Minnesota 56601|
|MeritCare Broadway||Fargo, North Dakota 58122|
|CCOP - MeritCare Hospital||Fargo, North Dakota 58122|
|Sanford Cancer Center at Sanford USD Medical Center||Sioux Falls, South Dakota 57117-5039|
|Medical X-Ray Center, PC||Sioux Falls, South Dakota 57105|
|Avera Cancer Institute||Sioux Falls, South Dakota 57105|
|John Stoddard Cancer Center at Iowa Methodist Medical Center||Des Moines, Iowa 50309|
|St. Vincent Mercy Medical Center||Toledo, Ohio 43608|
|CCOP - Toledo Community Hospital||Toledo, Ohio 43623-3456|
|Medical University of Ohio Cancer Center||Toledo, Ohio 43614|
|Toledo Hospital||Toledo, Ohio 43606|
|John Stoddard Cancer Center at Iowa Lutheran Hospital||Des Moines, Iowa 50316-2301|
|Mercy Capitol Hospital||Des Moines, Iowa 50307|
|Medical Oncology and Hematology Associates at John Stoddard Cancer Center||Des Moines, Iowa 50309|
|Medical Oncology and Hematology Associates at Mercy Cancer Center||Des Moines, Iowa 50314|
|Mercy Cancer Center at Mercy Medical Center - Des Moines||Des Moines, Iowa 50314|
|Hickman Cancer Center at Bixby Medical Center||Adrian, Michigan 49221|
|Community Cancer Center of Monroe||Monroe, Michigan 48162|
|Immanuel Medical Center||Omaha, Nebraska 68122|
|Creighton University Medical Center||Omaha, Nebraska 68131-2197|
|Bismarck Cancer Center||Bismarck, North Dakota 58501|
|Wood County Oncology Center||Bowling Green, Ohio 43402|
|Fremont Memorial Hospital||Fremont, Ohio 43420|
|Lima Memorial Hospital||Lima, Ohio 45804|
|St. Luke's Hospital||Maumee, Ohio 43537|
|Northwest Ohio Oncology Center||Maumee, Ohio 43537|
|Toledo Clinic - Oregon||Oregon, Ohio 43616|
|St. Charles Mercy Hospital||Oregon, Ohio 43616|
|North Coast Cancer Care, Incorporated||Sandusky, Ohio 44870|
|Firelands Regional Medical Center||Sandusky, Ohio 44870|
|Mercy Hospital of Tiffin||Tiffin, Ohio 44883|
|Toledo Clinic, Incorporated - Main Clinic||Toledo, Ohio 43623|
|Fulton County Health Center||Wauseon, Ohio 43567|
|McFarland Clinic, PC||Ames, Iowa 50010|
|Haematology-Oncology Associates of Ohio and Michigan, PC||Lambertville, Michigan 48144|
|Mercy Memorial Hospital - Monroe||Monroe, Michigan 48162|
|Alegant Health Cancer Center at Bergan Mercy Medical Center||Omaha, Nebraska 68124|
|Flower Hospital Cancer Center||Sylvania, Ohio 43560|
|Fredericksburg Oncology, Incorporated||Fredericksburg, Virginia 22401|
|Mid Dakota Clinic, PC||Bismarck, North Dakota 58501|
|Franciscan Skemp Healthcare - La Crosse Campus||La Crosse, Wisconsin 54601|
|Medcenter One Hospital Cancer Care Center||Bismarck, North Dakota 58501|
|St. Alexius Medical Center Cancer Center||Bismarck, North Dakota 58502|