| Co-Investigator(Kenkyū-buntansha) |
NISHIMURA Yasumasa Kinki University, Department of Radiology, Professor, 医学部, 教授 (00218207)
ARIYOSHI Yutaka Prefectural Aichih Hospital, Honorary director, 名誉院長
TAKADA Yoshiki Hyogo Prefectural Medical Center for Adult disease, Chief, 部長
NEGORO Syunichi Osaka City General Hospital, Chief, 部長
NAKANISHI Youich Chest of Department of Medicine Professor at Kyushu University Pulmonary Disease Research facilities, Professor, 医学部・胸部疾患研究施設, 助教授 (20172356)
植島 久雄 近畿大学, 医学部, 講師 (90232743)
原 信之 九州大学, 医学部・胸部疾患研究施設内科顧問, 教授 (90038802)
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| Budget Amount *help |
¥6,800,000 (Direct Cost: ¥6,800,000)
Fiscal Year 2004: ¥2,400,000 (Direct Cost: ¥2,400,000)
Fiscal Year 2003: ¥2,200,000 (Direct Cost: ¥2,200,000)
Fiscal Year 2002: ¥2,200,000 (Direct Cost: ¥2,200,000)
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| Research Abstract |
This study is a randomized trial of weekly irinotecan/carboplatin (IC) plus concurrent thoracic radiotherapy (TRT) versus weekly taxol/carboplatin (TC) plus concurrent TRT versus 4-weekly mitomycin/vindesine/cisplatin (MVP) plus concurrent TRT in patients with unresectable stage III non-small cell lung cancer (NSCLC). In this trial, standard dose chemotherapy of irinotecan and carboplatin taxol and carboplatin or mitomycin, vindesine and cisplatin are given after the completion of each chemoradiotherapy. Between September 2001 and December 2004,284 patients, 128 for IC arm, 128 for TC arm and 128 for MVP arm, were enrolled into the trial. Characteristics of patient are as follows : median age 65 years old (31-74 y.o.), male 109, female 19, stage IIIA 39, IIIB 89 in MVP arm, median age 65 y.o. (30-75 y.o.), male 110, female 18, stage IIIA 39, IIIB 89in IC arm, and median age 63 y.o. (38-74 y.o.), male 109, female 19, stage IIIA 39, stage IIIB 89 in TC arm. These patient characteristics are well balanced among the three arms. This trial is still ongoing, and will be continued until the total number of patients is 450. Primary endpoint of this trial is the overall survival, and secondary endpoints are response rate, progression-free survival and toxicities of each treatment.
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