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Colorectal CancerPhase 3NCT00147134

A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer

A Phase 3 study testing open colectomy and laparoscopic colectomy in people with Colorectal Cancer, run by Haruhiko Fukuda at 26 sites in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Colorectal Cancer
What is being tested?
open colectomy and laparoscopic colectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,050 participants
Where
26 sitesJapan
Study dates
Nov 2004to Mar 2014
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven colorectal carcinoma
  • Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
  • T3 or deeper lesion without involvement of other organs
  • Without multiple lesion other than carcinoma in situ
  • Cancer classified as N0-2 and M0, according to the TNM classification system
  • Tumor size < 8 cm
Show all 12Show fewer
  • No bowel obstruction
  • Age 20 < and > 75 years
  • Sufficient organ function
  • No history of gastrointestinal surgery
  • No history of chemotherapy or radiotherapy
  • Provided written informed consent

Who cannot join

  • Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
  • Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
  • Pregnant or lactating women
  • Severe mental disease
  • Continuous systemic steroid therapy

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

Japan26 sites

  • Tokyo Medical and Dental University Hospital

    Bunkyo-ku,Yushima,1-5-45, Tokyo, 113-8519

  • National Cancer Center Hospital

    Chuo-ku,Tsukiji,5-1-1, Tokyo, 104-0045

  • Hiroshima University, School of Medicine

    Hiroshima,Minami-ku,Kasumi,1-2-3, Hiroshima, 734-8551

  • Ishikawa Prefectual Central Hospital

    Kanazawa,Kuratsuki-Higashi,2-1, Ishikawa-ken, 920-8530

  • National Cancer Center Hospital East

    Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577

  • Teikyo University Hospital, Mizonokuchi

    Kawasaki,Takatsu-ku,Mizonokuchi,3-8-3, Kanagawa, 213-8507

  • Kurume University School of Medicine

    Kurume,Asahi-machi,67, Fukuoka, 830-0011

  • National Hospital Organization Kyoto Medical Center

    Kyoto,Fushimi-ku,Fukakusa,Mukaihata-cho,1-1, Kyoto, 612-8555

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama,Horinouchi,13, Ehime, 790-0007

  • Toho University Ohashi Hospital

    Meguro-ku,Ohashi,2-17-6, Tokyo, 153-0044

  • Toranomon Hospital

    Minato-ku,Toranomon,2-2-2, Tokyo, 105-8470

  • Kyorin University School of Medicine

    Mitaka,Shinkawa,6-20-2, Tokyo, 181-8611

  • Nagano Municipal Hospital

    Nagano,Tomitake,1333-1, Nagano, 381-8551

  • Osaka City General Hospital

    Osaka,Miyakojima-ku,Miyakojimahondori,2-13-22, Osaka, 534-0021

  • Kitasato University East Hospital

    Sagamihara,Asamizodai,2-1-1, Kanagawa, 228-8520

  • Kitasato University School of Medichine

    Sagamihara,Kitasato,1-15-1, Kanagawa, 228-8555

  • Omiya Medical Center, Jichi Medical School

    Saitama,Omiya-ku,Amanuma-cho,1-847, Saitama, 330-8503

  • Toho University Sakura Hospital

    Sakura,Shimoshidu,564-1, Chiba, 285-8741

  • Keio University Hospital

    Shinjuku-ku,Shinanomachi,35, Tokyo, 160-8582

  • Osaka University Graduate School of Medicine

    Suita,Yamada-oka,2-2, Osaka, 565-0871

  • Sizuoka Cancer Center

    Sunto-gun,Nagaizumi-cho,Shimonagakubo,1007, Shizuoka, 411-8777

  • Osaka Medical College

    Takatsuki,Daigakucho,2-7, Osaka, 569-0801

  • Fujita Health University

    Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192

  • Jyuntendo Urayasu Hospital

    Urayasu,Tomioka,2-1-1, Chiba, 279-0021

  • Showa University Northern Yokohama Hospital

    Yokohama,Tsuzuki-ku,Chigasakichuo,35-1, Kanagawa, 224-8503

  • Oita University Faculty of Medicine

    Yufu city,Hasama-machi, 1-1, Oita Prefecture, 879-5593

Other trials in Japan

About this study

Official title: Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer（JCOG 0404,CRC Surg-LAP/OPEN)

The purpose of this study is to evaluate oncological outcome of patients for T3 and T4 colorectal cancer undergoing laparoscopic versus open surgery.

Read the detailed description

The benefits of laparoscopic surgery (LAP) in comparison to open surgery (OPEN) have been suggested with respect to decreased morbidity, decreased pain, faster recovery, and shorter hospital stay.1-4 However, the long-term survival of LAP for colorectal cancer is still unclear, especially for advanced colorectal cancer requiring extended lymphadenectomy. Thus, the investigators designed a study which investigates whether LAP is suitable for advanced colorectal cancer with respect to survival and post-operative morbidity.

Being tested
open colectomy, laparoscopic colectomy
Keywords
colorectal cancer, laparoscopic surgery, randomized controlled trial, oncological outcome
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • open colectomyProcedure or surgery

    Procedure/Surgery: open colectomy

  • laparoscopic colectomyProcedure or surgery

    Procedure/Surgery: laparoscopic colectomy

Study groups in NCT00147134
Study groupRoleWhat they receive
1Active comparatorProcedure/Surgery: open colectomy
Receives: Procedure: open colectomy
2ExperimentalProcedure/Surgery: laparoscopic colectomy
Receives: Procedure: laparoscopic colectomy

What is being measured

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

  1. Overall survival

    Measured: During the study conduct

Secondary outcomes (5)

  1. Relapse-free survival

    Measured: During the study conduct

  2. Short-term clinical outcomes

    Measured: time to 1st discharge after operation

  3. Adverse events

    Measured: During the study conduct

  4. The proportion of conversion from LAP to OPEN

    Measured: operation day

  5. The proportion of completion of LAP

    Measured: operation day

Timeline

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

  1. First posted7 Sep 2005 (estimated)
  2. Study startNov 2004
  3. Primary completionMar 2014
  4. Study completionMar 2014

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,050 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00147134
Sponsor's protocol ID
JCOG0404
Other IDs
C000000105
Status last verified
Sep 2016
First submitted
5 Sep 2005
Last updated
22 Sep 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Saito S, Akagi T, Katayama H, Wakabayashi M, Inomata M, Yamamoto S, Ito M, Kinugasa Y, Egi H, Munakata Y, Kokuba Y, Bando H, Yasui M, Ikeda M, Nakajima K, Shida D, Kanemitsu Y, Kitano S; Colorectal Cancer Study Group of Japan Clinical Oncology Group. Identification of patient subgroups with unfavorable long-term outcomes associated with laparoscopic surgery in a randomized controlled trial comparing open and laparoscopic surgery for colon cancer (Japan Clinical Oncology Group Study JCOG0404). Ann Gastroenterol Surg. 2021 Aug 9;5(6):804-812. doi: 10.1002/ags3.12475. eCollection 2021 Nov.

    PubMed 34755012

  • Nishizawa Y, Akagi T, Inomata M, Katayama H, Mizusawa J, Yamamoto S, Ito M, Masaki T, Watanabe M, Shimada Y, Kitano S. Risk factors for early postoperative complications after D3 dissection for stage II or III colon cancer: Supplementary analysis of a multicenter randomized controlled trial in Japan (JCOG0404). Ann Gastroenterol Surg. 2019 Apr 4;3(3):310-317. doi: 10.1002/ags3.12246. eCollection 2019 May.

    PubMed 31131360

  • Fujii S, Akagi T, Inomata M, Katayama H, Mizusawa J, Ota M, Saito S, Kinugasa Y, Yamaguchi S, Sato T, Kitano S; Japan Clinical Oncology Group. Transitional impact of short- and long-term outcomes of a randomized controlled trial to evaluate laparoscopic versus open surgery for colorectal cancer from Japan Clinical Oncology Group Study JCOG0404. Ann Gastroenterol Surg. 2019 Mar 26;3(3):301-309. doi: 10.1002/ags3.12245. eCollection 2019 May.

    PubMed 31131359

  • Kitano S, Inomata M, Mizusawa J, Katayama H, Watanabe M, Yamamoto S, Ito M, Saito S, Fujii S, Konishi F, Saida Y, Hasegawa H, Akagi T, Sugihara K, Yamaguchi T, Masaki T, Fukunaga Y, Murata K, Okajima M, Moriya Y, Shimada Y. Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial. Lancet Gastroenterol Hepatol. 2017 Apr;2(4):261-268. doi: 10.1016/S2468-1253(16)30207-2. Epub 2017 Feb 2.

    PubMed 28404155

  • Yamamoto S, Inomata M, Katayama H, Mizusawa J, Etoh T, Konishi F, Sugihara K, Watanabe M, Moriya Y, Kitano S; Japan Clinical Oncology Group Colorectal Cancer Study Group. Short-term surgical outcomes from a randomized controlled trial to evaluate laparoscopic and open D3 dissection for stage II/III colon cancer: Japan Clinical Oncology Group Study JCOG 0404. Ann Surg. 2014 Jul;260(1):23-30. doi: 10.1097/SLA.0000000000000499.

    PubMed 24509190

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing open colectomy and laparoscopic colectomy in people with Colorectal Cancer, run by Haruhiko Fukuda at 26 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 5 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 22 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 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 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?

Overall survival (time frame: During the study conduct). 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 NCT00147134, which also lists 5 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 22 Sep 2016.

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