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

September 2, 2008 updated by: University of Toyama

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
      • Hiroshima, Japan, 730-8518
        • Not yet recruiting
        • Hiroshima City Hospital
        • Contact:
        • Principal Investigator:
          • Yasuo Iwamoto, MD
      • Osaka, Japan, 534-0021
        • Recruiting
        • Osaka City General Hospital
        • Contact:
      • Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Masahiro Tsuboi, MD
      • Toyama, Japan, 930-0194
        • Recruiting
        • Toyama University Hospital
        • Contact:
        • Principal Investigator:
          • Tatsuhiko Kashii, MD, PhD
      • Toyama, Japan, 930-0859
        • Recruiting
        • Toyama Red Cross Hospital
        • Contact:
        • Principal Investigator:
          • Keiichi Iwase, MD
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Recruiting
        • Toho University Sakura Medical Center
        • Contact:
        • Principal Investigator:
          • Ryoji Kato, MD
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-8648
        • Recruiting
        • Hokkaido University Hospital
        • Contact:
        • Principal Investigator:
          • Satoshi Oizumi, MD
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
        • Recruiting
        • Kanazawa University Hospital
        • Contact:
        • Principal Investigator:
          • Kazuo Kasahara, MD
      • Uchinada, Ishikawa, Japan, 920-0293
        • Recruiting
        • Kanazawa Medical University Hospital
        • Contact:
        • Principal Investigator:
          • Hirohisa Toga, MD
    • Nara
      • Ikoma, Nara, Japan, 630-0293
        • Recruiting
        • Kinkidaigakuigakubu Nara Hospital
        • Contact:
        • Principal Investigator:
          • Toshio Shimizu, MD
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
        • Recruiting
        • Kurashiki Central Hospital
        • Contact:
        • Principal Investigator:
          • Hirishige Yoshioka, MD
    • Osaka
      • Habikino, Osaka, Japan, 583-8588
        • Recruiting
        • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases
        • Contact:
        • Principal Investigator:
          • Tomonori Hirasima, MD
      • Sakai, Osaka, Japan, 590-0132
        • Not yet recruiting
        • Kinkidaigakuigakubu Sakai Hospital
        • Contact:
        • Principal Investigator:
          • Minoru Takada, MD
      • Sakai, Osaka, Japan, 591-8555
        • Recruiting
        • NHO Kinki-Chuo Chest Medical Center
        • Contact:
        • Principal Investigator:
          • Akihito Kubo, MD
      • Takatsuki, Osaka, Japan, 569-8686
        • Recruiting
        • Osaka Medikal College Hospital
        • Contact:
        • Principal Investigator:
          • Takayasu Kurata, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Cisplatin: CDDP
Drug: Krestin
Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.
Other Names:
  • Krestin: PSK

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Overall survival rate
Time Frame: one year
one year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Toyama

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Tatsuhiko Kashii, MD, PhD, Research Network for Chemotherapy of Lung Cancer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2007

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2011

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 17, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 17, 2007

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2008

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2008

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RNCLC-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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