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Small Cell Lung CancerPhase 2RNCLCNCT00546130

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

A Phase 2 study testing Irinotecan hydrochloride, Cisplatin and Krestin in people with Small Cell Lung Cancer, run by University of Toyama at 15 sites in Japan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 20 to 74 years
Conditions the study is for
Small Cell Lung Cancer
What is being tested?
Irinotecan hydrochloride, Cisplatin and Krestin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
15 sitesJapan
Study dates
Nov 2007to Sep 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

15 sites in 1 country.

Tatsuhiko Kashii, MD, PhD contact

+81-76-434-7808

tkashii@med.u-toyama.ac.jp

15 sites in 1 country

Japan15 sites, 15 recruiting

  • Osaka Prefectural Medical Center for Respiratory and Allergic Diseases

    Habikino, Osaka, 583-8588

    Tomonori Hirasima, MD, +81-957-2121, hirashima@opho.jp

    Tomonori Hirasima, MD

    Recruiting

  • Hiroshima City Hospital

    Hiroshima, Hiroshima, 730-8518

    Yasuo Iwamoto, MD, +81-82-221-2291, y-iwamoto@do.enjoy.ne.jp

    Yasuo Iwamoto, MD

    Not yet recruiting

  • Kinkidaigakuigakubu Nara Hospital

    Ikoma, Nara, 630-0293

    Toshio Shimizu, MD, +81-743-77-0880, tshimizu@nara.med.kindai.ac.jp

    Toshio Shimizu, MD

    Recruiting

  • Kanazawa University Hospital

    Kanazawa, Ishikawa-ken, 920-8641

    Kazuo Kasahara, MD, +81-076-265-2000, kasa1237@med3.m.kanazawa-u.ac.jp

    Kazuo Kasahara, MD

    Recruiting

  • Kurashiki Central Hospital

    Kurashiki, Okayama-ken, 710-8602

    Hiroshige Yoshioka, MD, +81-86-422-0210, hirotin@kchnet.or.jp

    Hirishige Yoshioka, MD

    Recruiting

  • Kanazawa Medical University Hospital

    Mukai-awagasaki, Ishikawa-ken, 920-0293

    Hirohisa Toga, MD, +81-76-286-3511, toga-h@kanazawa-med.ac.jp

    Hirohisa Toga, MD

    Recruiting

  • Osaka City General Hospital

    Osaka, Osaka, 534-0021

    Koji Takeda, MD, +81-6-6929-1221, kkk-take@ga2.so-net.ne.jp

    Koji Takeda, MD

    Recruiting

  • Kinkidaigakuigakubu Sakai Hospital

    Sakai, Osaka, 590-0132

    Minoru Takada, MD, +81-72-299-1120, m-takada@sakai.med.kindai.ac.jp

    Minoru Takada, MD

    Not yet recruiting

  • NHO Kinki-chuo Chest Medical Center

    Sakai, Osaka, 591-8555

    Akihito Kubo, MD, +81-72-252-3021, a-kubo@kch.hosp.go.jp

    Akihito Kubo, MD

    Recruiting

  • Toho University Sakura Medical Center

    Sakura, Chiba, 285-8741

    Ryoji Kato, MD, +81-43-462-8811, ryochan@sakura.med.toho-u.ac.jp

    Ryoji Kato, MD

    Recruiting

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648

    Satoshi Oizumi, MD, +81-11-716-1161, soizumi@med.hokudai.ac.jp

    Satoshi Oizumi, MD

    Recruiting

  • Osaka Medikal College Hospital

    Takatsuki, Osaka, 569-8686

    Takayasu Kurata, MD, +81-72-683-1221, ctc002@poh.osaka-med.ac.jp

    Takayasu Kurata, MD

    Recruiting

  • Tokyo Medical University Hospital

    Tokyo, Tokyo, 160-0023

    Masahiro Tsuboi, MD, +81-3-3342-6111, mtsuboi@za2.so-net.ne.jp

    Masahiro Tsuboi, MD

    Recruiting

  • Toyama University Hospital

    Toyama, Toyama, 930-0194

    Tatsuhiko Kashii, MD, PhD, +81-76-434-7808, tkashii@med.u-toyama.ac.jp

    Tatsuhiko Kashii, MD, PhD

    Recruiting

  • Toyama Red Cross Hospital

    Toyama, Toyama, 930-0859

    Keiichi Iwase, MD, +81-76-433-2222, iwasa@toyama-med.jrc.or.jp

    Keiichi Iwase, MD

    Recruiting

Other trials in Japan

About this 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

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.

Read the 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.

Being tested
Irinotecan hydrochloride, Cisplatin, Krestin
Keywords
ED-SCLC, small cell lung cancer, CPT-11, irinotecan hydrochloride, CDDP, cisplatin, PSK, Krestin
Medical subject headings
Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Irinotecan hydrochlorideDrug

    Also called Irinotecan hydrochloride: CPT-11

    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.

  • CisplatinDrug

    Also called Cisplatin: CDDP

    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.

  • KrestinDrug

    Also called Krestin: PSK

    Krestin 3,000 mg, PO everyday until progression or unacceptable toxicity develops.

Study groups in NCT00546130
Study groupRoleWhat they receive
1ExperimentalIrinotecan hydrochloride + Cisplatin + Krestin Therapy
Receives: Drug: Irinotecan hydrochloride; Drug: Cisplatin; Drug: Krestin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival rate

    Measured: one year

Secondary outcomes (1)

  1. Response rate, Time to treatment failure (TTF), Time to progression (TTP), Progression free survival (PFS), Severity and frequency of toxicity

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2007 (estimated)
  2. Study startNov 2007
  3. Primary completionSep 2011 (estimated)
  4. Study completionSep 2011 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00546130
Sponsor's protocol ID
RNCLC-01
Acronym
RNCLC
Status last verified
Aug 2008
First submitted
17 Oct 2007
Last updated
3 Sep 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Noda 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.

    PubMed 11784874

  • Fisher 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.

    PubMed 14731333

  • Saijo 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.

    PubMed 14676791

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Irinotecan hydrochloride, Cisplatin and Krestin in people with Small Cell Lung Cancer, run by University of Toyama at 15 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Tatsuhiko Kashii, MD, PhD (+81-76-434-7808, tkashii@med.u-toyama.ac.jp), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival rate (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546130, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2008.

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