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
OBJECTIVES:
- 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
3 years.
PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Maximum tolerated dose (MTD) as assessed by dose-limiting toxicity within 1 month after completion of study treatment (phase I)
Yes
Steven E. Schild, MD
Study Chair
Mayo Clinic
United States: Federal Government
CDR0000069250
NCT00032032
May 2002
Name | Location |
---|---|
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 |