Gastric NeoplasmPhase 3NCT00112099
GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
A Phase 3 study testing Surgery: Splenectomy and Surgery: Spleen-preservation in people with Gastric Neoplasm, run by Haruhiko Fukuda at 35 sites in Japan.
Trial summary
The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Gastric Neoplasm
- What is being tested?
- Surgery: Splenectomy and Surgery: Spleen-preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 35 sitesJapan
- Study dates
- Jun 2002to 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
- Preoperatively
- Histologically proven adenocarcinoma
- T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci
- No distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
- Sufficient organ function
- Written informed consent.
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- Intra-operatively
- T2/T3/T4 and N0/N1/N2, no tumor on the greater curvature, no direct invasion of the pancreas or spleen, negative peritoneal lavage cytology
- No apparent nodal metastasis in the splenic hilum or along the splenic artery
Who cannot join
- Liver cirrhosis or portal hypertension
- Idiopathic thrombocytopenic purpura
- Severe pulmonary dysfunction
- Synchronous or metachronous (within 5 years) malignancy.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
Tokyo Metropolitan Komagome Hospital
Bunkyo-ku,Honkomagome,3-18-22, Tokyo, 113-8677
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
Gifu Municipal Hospital
Gifu,Kashima-cho,7-1, Gifu, 500-8323
Hiroshima City Hospital
Hiroshima,Naka-ku,Motomachi,7-33, Hiroshima, 730-8518
Itami City Hospital
Itami,Koyaike,1-100, Hyōgo, 664-8540
Kagoshima University,Faculty of Medicine
Kagoshima,Sakuragaoka,8-35-1, Kagoshima-ken, 890-8520
National Cancer Center Hospital East
Kashiwa,Kashiwanoha,6-5-1, Chiba, 277-8577
Saitama Cancer Center
Kita-adachi,Ina,Komuro,818, Saitama, 362-0806
Cancer Institute Hospital
Koto-ku,Ariake,3-10-6, Tokyo, 135-8550
Kyoto Second Red Cross Hospital
Kyoto,Kamigyo-ku,Kamanza-Marutamachi,355-5, Kyoto, 602-8026
National Hospital Organization Shikoku Cancer Center
Matsuyama,Horinouchi,13, Ehime, 790-0007
Iwate Medical University
Morioka,Uchimaru,19-1, Iwate, 020-8505
Nagaoka Chuo General Hospital
Nagaoka,Kawasaki,2041, Niigata, 940-8653
Aichi Cancer Center Hospital
Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi-ken, 464-8681
Miyagi Cancer Center
Natori,Medeshima-Shiode,Nodayama,47-1, Miyagi, 981-1293
Niigata Cancer Center Hospital
Niigata,Kawagishi-cho,2-15-3, Niigata, 951-8566
Oita University Fuculty of Medicine
Oita1-1,Hasama-machi,Oogaoka, Oita Prefecture, 879-5593
Kinki University School of Medicine
Osaka-Sayama,Ohno-higashi,377-2, Osaka, 589-8511
Osaka National Hospital
Osaka,Chuo-ku,Hoenzaka,2-1-14, Osaka, 540-0006
Osaka Medical Center for Cancer and Cardiovascular Diseases
Osaka,Higashinari-ku,Nakamichi,1-3-3, Osaka, 537-8511
Sakai Municipal Hospital
Sakai,Minamiyasuicho,1-1-1, Osaka, 590-0064
National Hospital Organization, Sendai Medical Center
Sendai,Miyagino-ku,Miyagino,2-8-8, Miyagi, 983-8520
International Medical Center of Japan
Shinjuku-ku,Toyama,1-21-1, Tokyo, 162-8655
Shizuoka General Hospital
Shizuoka,Aoi-ku,Kitaando,4-27-1, Shizuoka, 420-8527
Tokyo Metropolitan Bokutoh Hospital
Sumida-ku,Koutoubashi,4-23-15, Tokyo, 130-8575
Osaka Medical College
Takatsuki,Daigakucho,2-7, Osaka, 569-0801
National Defense Medical College
Tokorozawa,Namiki,3-2, Saitama, 359-8513
Toyama Prefectural Central Hospital
Toyama,Nishinagae,2-2-78, Toyama, 930-8550
Fujita Health University
Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi-ken, 470-1192
Toyonaka Municipal Hospital
Toyonaka,Shibaharacho,4-14-1, Osaka, 560-0055
Tsubame Rosai Hospital
Tsubame,Sawatari,633, Niigata, 959-1228
Wakayama Medical University, School of Medicine
Wakayama,Kimiidera,811-1, Wakayama, 641-8510
Yamagata Prefectural Central Hospital
Yamagata,Aoyagi,1800, Yamagata, 990-2292
Kanagawa Cancer Center
Yokohama,Asahi-ku,Nakao,1-1-2, Kanagawa, 241-0815
About this study
Official title: Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
Read the detailed description
European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.
Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
- Conditions
- Gastric Neoplasm
- Being tested
- Surgery: Splenectomy, Surgery: Spleen-preservation
- Keywords
- gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery: SplenectomyProcedure or surgery
Procedure/Surgery: Surgery: Splenectomy
Surgery: Spleen-preservationProcedure or surgery
Procedure/Surgery: Surgery: Spleen-preservation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Procedure/Surgery: Surgery: Splenectomy Receives: Procedure: Surgery: Splenectomy |
| 2 | Experimental | Procedure/Surgery: Surgery: Spleen-preservation Receives: Procedure: Surgery: Spleen-preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: During the study conduct
Secondary outcomes (3)
Post-operative morbidity
Measured: 5 years
operation time
Measured: day of the operation
perioperative blood loss
Measured: 3 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2005 (estimated)
- Study startJun 2002
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haruhiko Fukuda
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Responsible party
- Sponsor-investigator, Haruhiko Fukuda, Japan Clinical Oncology Group
- Investigators
- Mitsuru Sasako, MD, PhD, Study chair, Hyogo Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00112099
- Sponsor's protocol ID
- JCOG 0110
- Other IDs
- C000000004
- Status last verified
- Sep 2016
- First submitted
- 27 May 2005
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sano T, Yamamoto S, Sasako M; Japan Clinical Oncology Group Study LCOG 0110-MF. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma: Japan clinical oncology group study JCOG 0110-MF. Jpn J Clin Oncol. 2002 Sep;32(9):363-4. doi: 10.1093/jjco/hyf085.
PubMed 12417603
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
- ClinicalTrials.gov ID
- NCT00112099
- Acronym / sponsor ID
- JCOG 0110
- Conditions
- Gastric Neoplasm
- Keywords
- gastric neoplasm, gastrectomy, splenectomy, randomized trial, T2, T3 and T4 carcinoma in the proximal third of the stomach
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Haruhiko FukudaUniversity, hospital or other
- Collaborators
- Ministry of Health, Labour and Welfare, Japan
- Study start
- Jun 2002
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 30 May 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the role of splenectomy in potentially curative total gastrectomy for proximal gastric carcinoma in terms of survival benefit and post-operative morbidity.
Detailed description
European clinical trials of gastrectomy showed that splenectomy is an important risk factor for post-operative morbidity and mortality. Retrospective comparisons suggested that splenectomy is associated with poor long term survival. However, Japanese studies revealed that 20 - 30 % of patients with non-early carcinoma in the proximal stomach have nodal metastasis in the splenic hilum and therefore, pancreas-preserving splenectomy is part of the standard operation in specialized centers where splenectomy is not considered a risk factor for operative mortality. There have been no prospective randomized trials to evaluate the survival benefit of splenectomy in total gastrectomy for proximal gastric cancer.
Comparison: Total gastrectomy with pancreas-preserving splenectomy versus total gastrectomy without splenectomy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: Surgery: SplenectomyProcedure/Surgery: Surgery: Splenectomy |
| 2 | Experimental | Procedure: Surgery: Spleen-preservationProcedure/Surgery: Surgery: Spleen-preservation |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Preoperatively
- Histologically proven adenocarcinoma
- T2 or deeper lesion in the upper third of the stomach without involvement of the greater curvature or esophageal invasion, irrespective of the primary tumor location or existence of multiple foci
- No distant metastasis, not linitis plastica ('Borrmann 4'), not stump carcinoma, no prior treatment for 364 Randomized trial for splenectomy gastric cancer
- Sufficient organ function
Key exclusion criteria (4 listed)
- Liver cirrhosis or portal hypertension
- Idiopathic thrombocytopenic purpura
- Severe pulmonary dysfunction
- Synchronous or metachronous (within 5 years) malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgery: SplenectomyProcedure/Surgery: Surgery: Splenectomy | Procedure or surgery | 1 |
| Surgery: Spleen-preservationProcedure/Surgery: Surgery: Spleen-preservation | Procedure or surgery | 2 |
Primary outcome
Overall survival
Time frame: During the study conduct
3 secondary outcomes
Post-operative morbidity
Time frame: 5 years
operation time
Time frame: day of the operation
perioperative blood loss
Time frame: 3 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Background: PubMed 12417603Sano T, Yamamoto S, Sasako M; Japan Clinical Oncology Group Study LCOG 0110-MF. Randomized controlled trial to evaluate splenectomy in total gastrectomy for proximal gastric carcinoma: Japan clinical oncology group study JCOG 0110-MF. Jpn J Clin Oncol. 2002 Sep;32(9):363-4. doi: 10.1093/jjco/hyf085.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitsuru Sasako, MD, PhD study chair
Hyogo Medical University
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Surgery: Splenectomy and Surgery: Spleen-preservation in people with Gastric Neoplasm, run by Haruhiko Fukuda at 35 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 9 inclusion and 4 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 35 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 NCT00112099, 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 22 Sep 2016.