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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

Phase 2
20 Years
74 Years
Open (Enrolling)
Small Cell Lung Cancer

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Trial Information

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

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.

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

- 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

- 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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival rate

Outcome Time Frame:

one year

Safety Issue:


Principal Investigator

Tatsuhiko Kashii, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Research Network for Chemotherapy of Lung Cancer


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

November 2007

Completion Date:

September 2011

Related Keywords:

  • Small Cell Lung Cancer
  • small cell lung cancer
  • CPT-11
  • irinotecan hydrochloride
  • CDDP
  • cisplatin
  • PSK
  • Krestin
  • Lung Neoplasms
  • Small Cell Lung Carcinoma