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Sponsored by: |
University of Toyama |
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Information provided by: | University of Toyama |
ClinicalTrials.gov Identifier: | NCT00546130 |
The purpose of this study is to examine whether setting test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation and comparing with historical control or community control is appropriate as the protocol and regimen for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer.
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: Irinotecan hydrochloride Drug: Cisplatin Drug: Krestin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Feasibility Study for Multicenter Randomized Controlled Phase III Clinical Trial of Cisplatin + Irinotecan Therapy and Cisplatin + Irinotecan + Krestin Therapy for Extensive-Stage Disease (ED) Small Cell Lung Cancer |
Estimated Enrollment: | 45 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
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Drug: Irinotecan hydrochloride
Irinotecan hydrochloride 60 mg/m2, IV (in the vein) on days 1, 8, 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Cisplatin 60 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
Drug: Krestin
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
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To examine whether the following protocol and regimen is appropriate for the phase III clinical trial on extensive-stage disease (ED) small cell lung cancer: set test groups of cisplatin + irinotecan + Krestin therapy as first-line treatment and chemotherapy (radiotherapy or radiotherapy + chemotherapy also allowed) combined with Krestin as second-line treatment after exacerbation, evaluate the efficacy and safety of treatment in a small number of cases, and compare with historical control or community control.
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients diagnosed as ED* by full staging [chest X ray, chest C, brain CT or MRI, abdominal CT or abdominal ultrasonography, whole body bone scintigraphy (may be replaced by PET/CT)]
Exclusion Criteria:
Contact: Tatsuhiko Kashii, MD, PhD | +81-76-434-7808 | tkashii@med.u-toyama.ac.jp |
Japan | |
Hiroshima City Hospital | Not yet recruiting |
Hiroshima, Japan, 730-8518 | |
Contact: Yasuo Iwamoto, MD +81-82-221-2291 y-iwamoto@do.enjoy.ne.jp | |
Principal Investigator: Yasuo Iwamoto, MD | |
Osaka City General Hospital | Recruiting |
Osaka, Japan, 534-0021 | |
Contact: Koji Takeda, MD +81-6-6929-1221 kkk-take@ga2.so-net.ne.jp | |
Principal Investigator: Koji Takeda, MD | |
Tokyo Medical University Hospital | Recruiting |
Tokyo, Japan, 160-0023 | |
Contact: Masahiro Tsuboi, MD +81-3-3342-6111 mtsuboi@za2.so-net.ne.jp | |
Principal Investigator: Masahiro Tsuboi, MD | |
Toyama University Hospital | Recruiting |
Toyama, Japan, 930-0194 | |
Contact: Tatsuhiko Kashii, MD, PhD +81-76-434-7808 tkashii@med.u-toyama.ac.jp | |
Principal Investigator: Tatsuhiko Kashii, MD, PhD | |
Toyama Red Cross Hospital | Recruiting |
Toyama, Japan, 930-0859 | |
Contact: Keiichi Iwase, MD +81-76-433-2222 iwasa@toyama-med.jrc.or.jp | |
Principal Investigator: Keiichi Iwase, MD | |
Japan, Chiba | |
Toho University Sakura Medical Center | Recruiting |
Sakura, Chiba, Japan, 285-8741 | |
Contact: Ryoji Kato, MD +81-43-462-8811 ryochan@sakura.med.toho-u.ac.jp | |
Principal Investigator: Ryoji Kato, MD | |
Japan, Hokkaido | |
Hokkaido University Hospital | Recruiting |
Sapporo, Hokkaido, Japan, 060-8648 | |
Contact: Satoshi Oizumi, MD +81-11-716-1161 soizumi@med.hokudai.ac.jp | |
Principal Investigator: Satoshi Oizumi, MD | |
Japan, Ishikawa | |
Kanazawa University Hospital | Recruiting |
Kanazawa, Ishikawa, Japan, 920-8641 | |
Contact: Kazuo Kasahara, MD +81-076-265-2000 kasa1237@med3.m.kanazawa-u.ac.jp | |
Principal Investigator: Kazuo Kasahara, MD | |
Kanazawa Medical University Hospital | Recruiting |
Uchinada, Ishikawa, Japan, 920-0293 | |
Contact: Hirohisa Toga, MD +81-76-286-3511 toga-h@kanazawa-med.ac.jp | |
Principal Investigator: Hirohisa Toga, MD | |
Japan, Nara | |
Kinkidaigakuigakubu Nara Hospital | Recruiting |
Ikoma, Nara, Japan, 630-0293 | |
Contact: Toshio Shimizu, MD +81-743-77-0880 tshimizu@nara.med.kindai.ac.jp | |
Principal Investigator: Toshio Shimizu, MD | |
Japan, Okayama | |
Kurashiki Central Hospital | Recruiting |
Kurashiki, Okayama, Japan, 710-8602 | |
Contact: Hiroshige Yoshioka, MD +81-86-422-0210 hirotin@kchnet.or.jp | |
Principal Investigator: Hirishige Yoshioka, MD | |
Japan, Osaka | |
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases | Recruiting |
Habikino, Osaka, Japan, 583-8588 | |
Contact: Tomonori Hirasima, MD +81-957-2121 hirashima@opho.jp | |
Principal Investigator: Tomonori Hirasima, MD | |
NHO Kinki-chuo Chest Medical Center | Recruiting |
Sakai, Osaka, Japan, 591-8555 | |
Contact: Akihito Kubo, MD +81-72-252-3021 a-kubo@kch.hosp.go.jp | |
Principal Investigator: Akihito Kubo, MD | |
Kinkidaigakuigakubu Sakai Hospital | Not yet recruiting |
Sakai, Osaka, Japan, 590-0132 | |
Contact: Minoru Takada, MD +81-72-299-1120 m-takada@sakai.med.kindai.ac.jp | |
Principal Investigator: Minoru Takada, MD | |
Osaka Medikal College Hospital | Recruiting |
Takatsuki, Osaka, Japan, 569-8686 | |
Contact: Takayasu Kurata, MD +81-72-683-1221 ctc002@poh.osaka-med.ac.jp | |
Principal Investigator: Takayasu Kurata, MD |
Study Chair: | Tatsuhiko Kashii, MD, PhD | Research Network for Chemotherapy of Lung Cancer |
Responsible Party: | Toyama University Hospital ( Tatsuhiko Kashii, MD, PhD, Associate Professor ) |
Study ID Numbers: | RNCLC-01 |
Study First Received: | October 17, 2007 |
Last Updated: | September 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00546130 |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
ED-SCLC small cell lung cancer CPT-11 irinotecan hydrochloride |
CDDP cisplatin PSK Krestin |
Thoracic Neoplasms Carcinoma, Neuroendocrine Interferons Irinotecan Camptothecin Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors |
Cisplatin Respiratory Tract Diseases Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma PS-K Neoplasms, Glandular and Epithelial |
Interferon Inducers Anti-Infective Agents Respiratory Tract Neoplasms Radiation-Protective Agents Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Adjuvants, Immunologic |
Enzyme Inhibitors Antibiotics, Antineoplastic Protective Agents Antiviral Agents Pharmacologic Actions Neoplasms Neoplasms by Site Radiation-Sensitizing Agents Therapeutic Uses Antineoplastic Agents, Phytogenic |