A randomized study of three platinum-based chemotherapies with concurrent thoracic radiotherapy in patients with unresectable stage III non-small cell lung cancer

2004 Fiscal Year Final Research Report Summary

• Project/Area Number: 13557055
• Research Category: Grant-in-Aid for Scientific Research (B)
• Allocation Type: Single-year Grants
• Section: 展開研究
• Research Field: Respiratory organ internal medicine
• Research Institution: Kinki University
• Principal Investigator: FUKUOKA Masahiro Kinki University, Department of Medical Oncology, Professor, 医学部, 教授 (20047202)
• 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)
• Project Period (FY): 2001 – 2004
• Keywords: Lung Cancer / non-small cell cancer / Chemoradiotherapy method / stage III / Irinotecan / Pacritaxsel / Carboplatin / Cisplatin

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.

Research Products

• [Journal Article] Gefitinib-a novel targated approach to treating cance (2004)
  • Author(s): Herbst RS, Fukuoka M, Baselga J, Timeline
  • Journal Title: Nat Rev Cancer 4 Pages: 956-965
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Retrospective analysis of the predictive factors associated with the response and survival benefit of gefitinib in patients with advanced non-small-cell lung cancer (2004)
  • Author(s): Kaneda, H., Tamura, K., Kurata, T., Uejima, H., Nakagawa, K., Fukuoka, M.
  • Journal Title: Lung Cancer 46 Pages: 247-254
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Combination phase I study of nedaplatin and gemcitabine for advanced non-small-cell lung cancer (2004)
  • Author(s): Kurata, T., Tamura, K., Yamamoto, N., Nogami, T., Satoh, T., Kaneda, H., Nakagawa, K., Fukuoka, M.
  • Journal Title: Br J Cancer 90 Pages: 2092-2096
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Effect of re-treatment with gefitinib ('Iressa', ZD1839) after acquisition of resistance (2004)
  • Author(s): Kurata, T., Tamura, K., Kaneda, H., Nogami, T., Uejima, H., Asai, G., Nakagawa, K., Fukuoka, M.
  • Journal Title: Ann Oncol 15 Pages: 173-174
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Randomized phase II study of docetaxel/cisplatin versus docetaxel/irinotecan in advanced non-small cell lung cancer : a West Japan Thoracic Oncology Study(WJTOG9803) (2004)
  • Author(s): Yamamoto, N., Fukuoka, M., Negoro, S., Nakagawa, K., Saito, H., Matsui, K., Kawahara, M., Senba, H., Takada, Y., Kudoh, S., Nakano, T., Katakami, N., Sugiura, T., Hoso, T., Ariyoshi, Y.for the West Japan Thoracic Oncology Group.
  • Journal Title: Br J Cancer 90 Pages: 87-92
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Prediction of sensitivity of advanced non-small cell lung cancers to gefitinib(Iressa, ZD1839) (2004)
  • Author(s): Kakiuchi, S., Daigo, Y., Ishikawa, N., Furukawa, C., Tsunoda, T., Yano, S., Nakagawa, K., Tsuruo, T., Kohno, N., Fukuoka, M., Sone, S., Nakamura, Y.
  • Journal Title: Hum Mol Genet 13 Pages: 3029-3043
  • Description: 「研究成果報告書概要(和文)」より
• [Journal Article] Gefitinib-a novel targated approach to treating cance (2004)
  • Author(s): Herbst RS, Fukuoka M, Baselga J.Timeline
  • Journal Title: Nat Rev Cancer 4 Pages: 956-965
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Randomized phase II study of docetaxe1/cisplatin versus docetaxe1/ irinotecan in advanced non-small cell lung cancer : a West Japan Thoracic Oncology Study (WJTOG9803) (2004)
  • Author(s): Yamamoto, N., Fukuoka, M., Negoro, S., Nakagawa, K., Saito, H., Matsui, K., Kawahara, M., Senba, H., Takada, Y., Kudoh, S., Nakano, T., Katakami, N., Sugiura, T., Hoso, T., Ariyoshi, Y.for the West Japan Thoracic Oncology Group.
  • Journal Title: Br J Cancer 90 Pages: 87-92
  • Description: 「研究成果報告書概要(欧文)」より
• [Journal Article] Prediction of sensitivity of advanced non-small cell lung cancers to gefitinib (Iressa, ZD1839) (2004)
  • Author(s): Kakiuchi S, Daigo Y, Ishikawa N, Furukawa C, Tsunoda T, Yano S, Nakagawa K, Tsuruo T, Kohno N, Fukuoka M, Sone S, Nakamura Y.
  • Journal Title: Hum Mol Genet 13 Pages: 3029-3043
  • Description: 「研究成果報告書概要(欧文)」より