97
Participants
Start Date
August 15, 2002
Primary Completion Date
September 30, 2009
Study Completion Date
October 31, 2009
cisplatin
"Days 1 - 35 : Cisplatin 30 mg/m² days 1, 8, 15, 22, 29~Days 63 - 77 : cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
irinotecan hydrochloride
"Days 1 - 35 : Irinotecan 65 mg/m² days 1, 8, 22, 29~Days 63 - 77 : irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
paclitaxel
"Days 1 - 35 : Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29~Days 63 - 77 : paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles"
conventional surgery
The type of resection (lvor-Lewis, Transhiatal, etc.) was left to the discretion of the operating surgeon. One lymph node dissection was required.
radiation therapy
The total dose to the prescription point was 4500 cGy given in 25 fractions. The patient was treated with one fraction per day with all fields treated per day. 180 cGy was delivered to the isocenter. If the dose to the supraclavicular fossa (SCF) was less than 4500 cGy, a localized photon or electron boost was allowed in order to increase the SCF dose to 4500 cGy, specified at 3 cm depth from the anterior skin surface.
CCOP - MainLine Health, Wynnewood
Lankenau Cancer Center at Lankenau Hospital, Wynnewood
CCOP - Christiana Care Health Services, Newark
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore
MetroHealth's Cancer Care Center at MetroHealth Medical Center, Cleveland
CCOP - Michigan Cancer Research Consortium, Ann Arbor
CCOP - Marshfield Clinic Research Foundation, Marshfield
St. Joseph's Hospital, Saint Paul
CCOP - Metro-Minnesota, Saint Louis Park
Mayo Clinic Cancer Center, Rochester
CCOP - Sioux Community Cancer Consortium, Sioux Falls
Robert H. Lurie Comprehensive Cancer Center at Northwestern University, Chicago
CCOP - Carle Cancer Center, Urbana
CCOP - Scott and White Hospital, Temple
CCOP - Colorado Cancer Research Program, Incorporated, Denver
Shands Cancer Center at the University of Florida Health Science Center, Gainesville
Veterans Affairs Medical Center - Lakeside Chicago, Chicago
CCOP - Iowa Oncology Research Association, Des Moines
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital, New Brunswick
Ireland Cancer Center, Cleveland
CCOP - Toledo Community Hospital, Toledo
CCOP - St. Vincent Hospital Cancer Center, Green Bay, Green Bay
University of Wisconsin Comprehensive Cancer Center, Madison
National Cancer Institute (NCI)
NIH
Eastern Cooperative Oncology Group
NETWORK