Clinical trial · Interventional
Feasibility Study of CDDP + CPT-11 + PSK for Extensive-Stage Disease (ED) Small Cell Lung Cancer
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
NCT00546130CI-TRIAL-00001663RNCLCunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
| Krestin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Irinotecan hydrochloride + Cisplatin + Krestin Therapy
- interventionNames
- Drug: Irinotecan hydrochloride
- Drug: Cisplatin
- Drug: Krestin
Primary outcomes (1)
- measure
- Overall survival rate
- timeFrame
- one year
Secondary outcomes (1)
- measure
- Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDNoda K, Nishiwaki Y, Kawahara M, Negoro S, Sugiura T, Yokoyama A, Fukuoka M, Mori K, Watanabe K, Tamura T, Yamamoto S, Saijo N; Japan Clinical Oncology Group. Irinotecan plus cisplatin compared with etoposide plus cisplatin for extensive small-cell lung cancer. N Engl J Med. 2002 Jan 10;346(2):85-91. doi: 10.1056/NEJMoa003034. PMID 11784874
- BACKGROUNDFisher MD, D'Orazio A. Irinotecan and cisplatin versus etoposide and cisplatin in small-cell lung cancer: JCOG 9511. Clin Lung Cancer. 2000 Aug;2(1):23-4. No abstract available. PMID 14731333
- BACKGROUNDSaijo N. Progress in treatment of small-cell lung cancer: role of CPT-11. Br J Cancer. 2003 Dec 15;89(12):2178-83. doi: 10.1038/sj.bjc.6601456. PMID 14676791