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Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer (RNCLC)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University of Toyama.
Recruitment status was:  Recruiting
Information provided by:
University of Toyama Identifier:
First received: October 17, 2007
Last updated: September 2, 2008
Last verified: August 2008
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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

Further study details as provided by University of Toyama:

Primary Outcome Measures:
  • Overall survival rate [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity [ Time Frame: one year ] [ Designated as safety issue: Yes ]

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
Experimental: 1
Irinotecan hydrochloride + Cisplatin + Krestin Therapy
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.

Other Name: Irinotecan hydrochloride: CPT-11
Drug: Cisplatin
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.
Other Name: Cisplatin: CDDP
Drug: Krestin
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Other Name: Krestin: PSK

Detailed Description:
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   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with histologically or cytologically proven small cell lung cancer
  • Patients receiving chemotherapy for the first time
  • Patients with no indication for radical radiotherapy or surgical resection
  • 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)]

    • ED: Patient with distant metastasis including contralateral hilar lymph node metastasis, but ipsilateral pleural effusion without distant metastasis is excluded.
  • Patients with lesions measurable or evaluable by the RECIST criteria
  • Patients aged from 20 years to below 75 years
  • Patients with preserved organ functions as indicated by the following test values (data obtained within 14 days prior to registration) Hemoglobin: ≥9.0 g/dL White blood cell count: ≥4,000/mm3, ≤12,000 /mm3 Neutrophil count: ≥ 2,000/mm3 Platelet count: ≥100,000 /mm3 GOT, GPT: below 2.5 times the upper limit of normal range for individual facility Total bilirubin: ≤1.5 mg/dL Serum creatinine: below the lower limit of normal range for individual facility Creatinine clearance: ≥ 60mL/min Arterial oxygen tension (PaO2): ≥60 torr (resting)
  • Performance status (PS): 0-1
  • Absence of serious concurrent cardiac or pulmonary disease
  • Patients expected to survive for at least 3 months
  • Patients from whom written informed consent can be obtained

Exclusion Criteria:

  • Patients with serious infection and other serious complications (including gastrointestinal bleeding and diarrhea)
  • Patients with pleural effusion, ascites, or pericardial effusion that requires treatments including puncture drainage and intracavity administration
  • Patients showing definite interstitial pneumonitis or pulmonary fibrosis on plain chest radiograph
  • Patients manifesting central nervous system symptoms due to brain metastasis at registration
  • Patients with active multiple cancers
  • Patients who had undergone bone marrow transplantation
  • Patients who had undergone peripheral blood stem cell transplantation
  • Patients with a history of definite drug allergy
  • Pregnant and nursing patients, patients who may be pregnant or who intend to become pregnant
  • Male patients with reproductive capacity who have no intention of contraception during the clinical trial
  • Patients with poorly controlled diabetes
  • Patients who had been administered Krestin in the past
  • Others: patients who are judged by the investigator or subinvestigator to be unsuitable as subject
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00546130

Toho University Sakura Medical Center
Sakura, Chiba, Japan, 285-8741
Hokkaido University Hospital
Sapporo, Hokkaido, Japan, 060-8648
Kanazawa University Hospital
Kanazawa, Ishikawa, Japan, 920-8641
Kanazawa Medical University Hospital
Uchinada, Ishikawa, Japan, 920-0293
Kinkidaigakuigakubu Nara Hospital
Ikoma, Nara, Japan, 630-0293
Kurashiki Central Hospital
Kurashiki, Okayama, Japan, 710-8602
Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
Habikino, Osaka, Japan, 583-8588
Kinkidaigakuigakubu Sakai Hospital
Sakai, Osaka, Japan, 590-0132
NHO Kinki-chuo Chest Medical Center
Sakai, Osaka, Japan, 591-8555
Osaka Medikal College Hospital
Takatsuki, Osaka, Japan, 569-8686
Hiroshima City Hospital
Hiroshima, Japan, 730-8518
Osaka City General Hospital
Osaka, Japan, 534-0021
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
Toyama University Hospital
Toyama, Japan, 930-0194
Toyama Red Cross Hospital
Toyama, Japan, 930-0859
Sponsors and Collaborators
University of Toyama
Study Chair: Tatsuhiko Kashii, MD, PhD Research Network for Chemotherapy of Lung Cancer
  More Information

Responsible Party: Tatsuhiko Kashii, MD, PhD, Associate Professor, Toyama University Hospital Identifier: NCT00546130     History of Changes
Other Study ID Numbers: RNCLC-01 
Study First Received: October 17, 2007
Last Updated: September 2, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by University of Toyama:
small cell lung cancer
irinotecan hydrochloride

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents processed this record on December 08, 2016