AzTrials
AzTrials

Gastric CancerPhase 2/3NCT00639327

Second Line Chemotherapy for S-1 Refractory Advanced Gastric Cancer

A Phase 2/3 study testing S-1 + irinotecan and irinotecan in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 86 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
S-1 + irinotecan and irinotecan
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
86 sitesJapan
Study dates
Mar 2008to Jun 2011
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven inoperable advanced gastric adenocarcinoma (including adenocarcinoma of the gastroesophageal junction) or relapse gastric adenocarcinoma
  • Subjects must be able to take orally
  • Subjects must be confirmed to be PD status by picture diagnosis after first-line chemotherapy using S-1 alone, S-1 + Cisplatinum or S-1 + taxane, except S-1 + CPT-11
  • Within 4 weeks from the diagnosis of PD
  • Total dosage of S-1 at the first-line is over 2,240mg/m2 in S-1 alone treatment, 1,680mg/m2 in the S-1 combination
  • ECOG performance status ≤ 1
Show all 12Show fewer
  • Follow up Age 20 or over
  • Life expectancy estimated more than 12 weeks
  • Hgb ≥ 8 g/dL, WBC 4,000-12,000/mm3, ANC ≥ 2,000/mm3, platelets ≥ 100,000/mm3
  • Creatinine ≤ upper normal limit (UNL)
  • Total bilirubin ≤ 1.5 X UNL
  • Written informed consent

Who cannot join

  • S-1 + CPT-11 was employed as a first-line
  • Any other cytotoxic agents therapy, immuno-therapy, radiation-therapy
  • After S-1 adjuvant
  • Suspended cases by adverse events by S-1 or S-1 combination
  • Excessive amounts of ascites require drainage
  • Known brain metastases
Show all 11Show fewer
  • History of hypersensitivity to fluoropyrimidines and CPT-11
  • Pregnancy or lactation women, or women with suspected pregnancy or men with willing to get pregnant
  • Active double cancer
  • Gastrointestinal bleeding
  • Any subject judged by the investigator to be unfit for any reason to participate in the study

Trial locations and contacts

86 sites in 1 country.

86 sites in 1 country

Japan86 sites

  • Nakadoori General Hospital

    Akita, Akita, 010-8577

  • Aomori Prefectural Central Hospital

    Aomori, Aomori, 030-8553

  • Asahikawa Medical College Department Medicine

    Asahikawa, Hokkaido, 078-8510

  • Asahikawa Medical College Hospital

    Asahikawa, Hokkaido, 078-8510

  • Nippon Medical School

    Bunkyo-ku, Tokyo, 113-8603

  • ChibaUniversity Hospital

    Chiba, Chiba, 260-8677

  • Surugadai Nihon University Hospital

    Chiyoda-ku, Tokyo, 101-8309

  • Fukui Red Cross Hospital

    Fukui-shi, Fukui, 918-8501

  • Saiseikai Hospital

    Fukui-shi, Fukui, 918-8503

  • Saiseikai Fukuoka General Hospital

    Fukuoka, Fukuoka, 810-0001

  • National Hospital Organization Kyushu Medical Center

    Fukuoka, Fukuoka, 810-8563

  • National Kyusyu Cancer Center

    Fukuoka, Fukuoka, 811-1395

  • Kyusyu University Faculty of Medical Sciences

    Fukuoka, Fukuoka, 812-8582

  • Fukushima Medical University

    Fukushima, Fukushima, 960-1295

  • Fukuyama City Hospital

    Fukuyama, Hiroshima, 721-8511

  • Gifu Municipal Hospital

    Gifu, Gifu, 500-8513

  • Gifu Prefectural General Medical Center

    Gifu, Gifu, 500-8717

  • Graduate School of Medicine, Gifu University

    Gifu, Gifu, 501-1193

  • Hakodate Goryoukaku Hopsital

    Hakodate, Hokkaido, 040-0001

  • Hirosahi University Graduate School of Medicine

    Hirosaki, Aomori, 036-8562

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Hiroshima University Research Institute for Radiation Biology and Medicine Tumor Surgery

    Hiroshima, Hiroshima, 734-8553

  • Tokai University Hospital

    Isehara, Kanagawa, 259-1193

  • Rinku General Medical Center

    Izumisano, Osaka, 598-0048

  • Shimane University Faculty of Medicine

    Izumo, Shimane, 693-8501

  • National Hospital Organization Kagoshima Medical Center

    Kagoshima, Kagoshima-ken, 892-0853

  • Ishikawa Prefectural Central Hospital

    Kanazawa, Ishikawa-ken, 920-8530

  • St.Marianna University School Of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Kagawa Medical University Hospital

    Kida, Kagawa-ken, 761-0793

  • Kimen Municipal Hospital

    Kimen, Osaka, 562-8562

  • Kirishima Medical Center

    Kirishima, Kagoshima-ken, 899-5112

  • Nippon Steel Yawata Memorial Hospital

    Kitakyushu, Fukuoka, 805-8508

  • Kochi Health Sciences Center

    Kochi, Kochi, 781-8555

  • Kumamoto Medical University Hospital

    Kumamoto, Kumamoto, 860-8556

  • Kurume University Hospital

    Kurume, Fukuoka, 830-0011

  • Gunma University Hospital

    Maehashi, Gunma, 371-0034

  • Kaneda Hospital

    Maniwa, Okayama-ken, 719-3105

  • Matsue City Hospital

    Matsue, Shimane, 690-8509

  • Toho University Ohhashi Medical Center

    Meguro-ku, Tokyo, 153-8515

  • Toranomon Hospital

    Minato-ku, Tokyo, 105-8470

  • The Jikei University

    Minato-ku, Tokyo, 105-8471

  • International University of Health and Welfare Mita Hospital

    Minato-ku, Tokyo, 108-8329

  • Iwate Prefectural Central Hospital

    Morioka, Iwate, 020-0066

  • Iwate Medical University Hospital

    Morioka, Iwate, 020-8505

  • Nagano Municipal Hospital

    Nagano, Nagano, 381-0006

  • Midori Municipal Hospital

    Nagoya, Aichi-ken, 458-0037

  • Nagoya City University Hospital

    Nagoya, Aichi-ken, 467-8602

  • Kanazawa Medical University Hospital

    Nakajima, Ishikawa-ken, 920-0293

  • Miyagi Cancer Center

    Natori-shi, Miyagi, 981-1293

  • Niigata Prefectural Cancer Center

    Niigata, Niigata, 951-8566

  • Yamamoto Hospital

    Noshiro, Akita, 016-0014

  • National Hospital Organization Okayama Medical Center

    Okayama, Okayama-ken, 701-1192

  • Aichi Medical University Hospital

    Okazaki, Aichi-ken, 480-1195

  • Gunma Prefectural Cancer Center

    Oota, Gunma, 373-8550

  • Toho University Omori Medical Center

    Oota-ku, Tokyo, 143-8541

  • Kitano Hospital

    Osaka, Osaka, 530-8480

  • Osaka City University Graduate School of Medicine

    Osaka, Osaka, 545-8585

  • Osaka Koseinenkin Hospital

    Osaka, Osaka, 553-0003

  • Osaka General Medical Center

    Osaka, Osaka, 558-8558

  • Saiseikai Shiga Hospital

    Rittō, Shiga, 520-3046

  • Saga Prefectural Hospital Kouseikan

    Saga, Saga-ken, 840-8571

  • Sakai Municipal Hospital

    Sakai, Osaka, 590-0064

  • Osaka Rosai Hospital

    Sakai, Osaka, 591-8025

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Sapporo Medical University Hospital

    Sapporo, Hokkaido, 060-8543

  • Institute of Development,Aging and Cancer,Tohoku University

    Sendai, Miyagi, 980-8574

  • Tohoku University School Of Medicine

    Sendai, Miyagi, 980-8574

  • Sendai Medical Center

    Sendai, Miyagi, 983-8520

  • Dokkyo University School of Medecine

    Shimotsuga, Tochigi, 321-0293

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Tokyo Women's Medical University Institute of Gastorenterology

    Shinjuku-ku, Tokyo, 162-8666

  • Suita Municipal Hospital Website

    Suita, Osaka, 564-0082

  • Metropolitan Bokutoh Hospital

    Sumida-ku, Tokyo, 130-8575

  • Hyogo Prefectural Awaji Hospital

    Sumoto, Hyōgo, 656-0017

  • Teikyo University Hospital

    tabashi City, Tokyo, 173-8606

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Saiseikai Takaoka Hospital

    Takaoka, Toyama, 933-8525

  • Kouseiren Takaoka Hospital

    Takaoka, Toyama, 933-8555

  • Toyama Prefectural Center Hospital

    Toyama, Toyama, 930-8550

  • Yamagata University Faculty Of Medicine

    Yamagata, Yamagata, 990-9585

  • Yao City Hospital

    Yao, Osaka, 581-0069

  • Showa University Northern Yokohama Hospital

    Yokohama, Kanagawa, 224-8503

  • Showa University Fujigaoka Hospital

    Yokohama, Kanagawa, 227-8501

  • Citizen's General Medical Center attached to Yokohama City University

    Yokohama, Kanagawa, 232-0024

  • Tottori University Faculty of Medicine

    Yonago, Tottori, 683-8504

  • University of Fukui Faculty of Medical Scieneces Hospital

    Yoshida-gun, Fukui, 910-1193

Other trials in Japan

About this study

Official title: Randomized Phase II/III Trial of Second Line Chemotherapy Comparing CPT-11 Monotherapy Versus S-1/CPT-11 Combination for S-1 Refractory Gastric Cancer

The purpose of this study is compare overall survival of the test arm (CPT-11/S-1 combination) to the control arm (CPT-11 alone) in the subjects with S-1 refractory advanced gastric cancer.

Read the detailed description

Standard chemotherapy for advanced gastric cancer (AGC) in the US is Cisplatin/5-FU (CF) or docetaxel/CF (DCF), is in Europe epirubicin/CF (ECF) or epirubicin/oxaliplatin/ capecitabine (EOX). Until 2006, there was no evidence of standard chemotherapy for AGC in Japan. In 2007, by the results of JCOG9912 trial (5-FU alone vs. CPT-11/CDDP vs S-1) and SPIRITS trial (S-1 alone vs. S-1/CDDP), S-1/CDDP is regarded as a new standard regimen in Japan. In 2008, by the results of TOP-002 trial (s-1 alone vs. S-1/CPT-11), S-1/CPT-11 could not show the superiority to S-1 alone. One of the other phase III trials, JACCRO GC-03 trial (S-1 alone vs. S-1/docetaxel, NCT00287768) is now ongoing. However, the position of CPT-11 in the treatment of AGC will be regarded as a second-line.

In Japan there is a controversy for the treatment of S-1 refractory gastric cancer. The controversy is continuing S-1 (like FOLFOX to FOLFIRI) or not as a second-line. After the successful adjuvant S-1 results (ACTS-GC trial), the same problem will occur in the patients who are recurrent from adjuvant S-1.

Then, we conducted a phase II/III trial of CPT-11 with or without S-1 in the treatment of first-line S-1 refractory AGC.

Conditions
Gastric Cancer
Being tested
S-1 + irinotecan, irinotecan
Keywords
Stomach Neoplasms, Second line chemotherapy, Refractory to S-1, irinotecan, S-1 and Irinotecan Combination, Phase III study
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • S-1 + irinotecanDrug

    Also called TS-1, CPT-11

    Irinotecan 150mg/m2 iv on day one and S-1 po days 1 to 14 every 3 weeks until PD

  • irinotecanDrug

    Also called CPT-11

    Irinotecan 150mg/m2 iv on day one every two weeks until PD

Study groups in NCT00639327
Study groupRoleWhat they receive
AExperimentalCPT-11+ S-1
Receives: Drug: S-1 + irinotecan
BActive comparatorCPT-11
Receives: Drug: irinotecan

What is being measured

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

  1. In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet.

    Measured: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization

Secondary outcomes (1)

  1. Adverse events, response rates, progression free survival, time to treatment failure, change over rates to 3rd line

    Measured: 2 years

Timeline

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

  1. First posted20 Mar 2008 (estimated)
  2. Study startMar 2008
  3. Primary completionApr 2011
  4. Study completionJun 2011

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00639327
Sponsor's protocol ID
JACCRO GC-05
Status last verified
Jun 2011
First submitted
5 Mar 2008
Last updated
28 Jun 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • Tanabe K, Fujii M, Nishikawa K, Kunisaki C, Tsuji A, Matsuhashi N, Takagane A, Ohno T, Kawase T, Kochi M, Yoshida K, Kakeji Y, Ichikawa W, Chin K, Terashima M, Takeuchi M, Nakajima T. Phase II/III study of second-line chemotherapy comparing irinotecan-alone with S-1 plus irinotecan in advanced gastric cancer refractory to first-line treatment with S-1 (JACCRO GC-05). Ann Oncol. 2015 Sep;26(9):1916-1922. doi: 10.1093/annonc/mdv265. Epub 2015 Jun 24.

    PubMed 26109630

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing S-1 + irinotecan and irinotecan in people with Gastric Cancer, run by Japan Clinical Cancer Research Organization at 86 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 11 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: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 86 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 combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

In phase II part, progressive disease rate will be measured for the safety. In phase III part, overall survival will be measured for the benefit of doublet. (time frame: Phase II: 6 weeks from treatment, Phase III: 2 years OS from randomization). 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 NCT00639327, which also lists 1 linked publication.

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 28 Jun 2011.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in