GCSSG-SPNX: Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110
This study is ongoing, but not recruiting participants.
Sponsor:
Japan Clinical Oncology Group
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00112099
First received: May 27, 2005
Last updated: August 2, 2009
Last verified: August 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Neoplasm |
Procedure: Surgery: Splenectomy Procedure: Surgery: Spleen-preservation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Controlled Trial to Evaluate Splenectomy in Total Gastrectomy for Proximal Gastric Carcinoma: JCOG0110 |
Resource links provided by NLM:
Further study details as provided by Japan Clinical Oncology Group:
Primary Outcome Measures:
- Overall survival [ Time Frame: During the study conduct ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Post-operative morbidity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- operation time [ Time Frame: day of the operation ] [ Designated as safety issue: Yes ]
- perioperative blood loss [ Time Frame: 3 days after operation ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | June 2002 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Procedure/Surgery: Surgery: Splenectomy
|
Procedure: Surgery: Splenectomy
Procedure/Surgery: Surgery: Splenectomy
|
|
Experimental: 2
Procedure/Surgery: Surgery: Spleen-preservation
|
Procedure: Surgery: Spleen-preservation
Procedure/Surgery: Surgery: Spleen-preservation
|
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
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
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.
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
Exclusion Criteria:
- Liver cirrhosis or portal hypertension
- Idiopathic thrombocytopenic purpura
- Severe pulmonary dysfunction
- Synchronous or metachronous (within 5 years) malignancy.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00112099
Locations
| Japan | |
| Aichi Cancer Center Hospital | |
| 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681 | |
| Fujita Health University | |
| 1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan, 470-1192 | |
| National Cancer Center Hospital East | |
| 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577 | |
| National Hospital Organization Shikoku Cancer Center | |
| 13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007 | |
| Gifu Municipal Hospital | |
| 7-1,Kashima-cho,Gifu, Gifu, Japan, 500-8323 | |
| Hiroshima City Hospital | |
| 7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan, 730-8518 | |
| Itami City Hospital | |
| 1-100,Koyaike,Itami, Hyogo, Japan, 664-8540 | |
| Iwate Medical University | |
| 19-1,Uchimaru,Morioka, Iwate, Japan, 020-8505 | |
| Kagoshima University,Faculty of Medicine | |
| 8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan, 890-8520 | |
| Kanagawa Cancer Center | |
| 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815 | |
| Kyoto Second Red Cross Hospital | |
| 355-5,Kamanza-Marutamachi,Kamigyo-ku,Kyoto, Kyoto, Japan, 602-8026 | |
| National Hospital Organization, Sendai Medical Center | |
| 2-8-8,Miyagino,Miyagino-ku,Sendai, Miyagi, Japan, 983-8520 | |
| Miyagi Cancer Center | |
| 47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293 | |
| Niigata Cancer Center Hospital | |
| 2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566 | |
| Nagaoka Chuo General Hospital | |
| 2041,Kawasaki,Nagaoka, Niigata, Japan, 940-8653 | |
| Tsubame Rosai Hospital | |
| 633,Sawatari,Tsubame, Niigata, Japan, 959-1228 | |
| Oita University Fuculty of Medicine | |
| 1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan, 879-5593 | |
| Sakai Municipal Hospital | |
| 1-1-1,Minamiyasuicho,Sakai, Osaka, Japan, 590-0064 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | |
| 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511 | |
| Osaka National Hospital | |
| 2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006 | |
| Osaka Medical College | |
| 2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801 | |
| Kinki University School of Medicine | |
| 377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511 | |
| Toyonaka Municipal Hospital | |
| 4-14-1,Shibaharacho,Toyonaka, Osaka, Japan, 560-0055 | |
| National Defense Medical College | |
| 3-2,Namiki,Tokorozawa, Saitama, Japan, 359-8513 | |
| Saitama Cancer Center | |
| 818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806 | |
| Shizuoka General Hospital | |
| 4-27-1,Kitaando,Aoi-ku,Shizuoka, Sizuoka, Japan, 420-8527 | |
| International Medical Center of Japan | |
| 1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan, 162-8655 | |
| Tokyo Medical and Dental University Hospital | |
| 1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Cancer Institute Hospital | |
| 3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550 | |
| Tokyo Metropolitan Komagome Hospital | |
| 3-18-22,Honkomagome,Bunkyo-ku, Tokyo, Japan, 113-8677 | |
| Tokyo Metropolitan Bokutoh Hospital | |
| 4-23-15,Koutoubashi,Sumida-ku, Tokyo, Japan, 130-8575 | |
| National Cancer Center Hospital | |
| 5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045 | |
| Toyama Prefectural Central Hospital | |
| 2-2-78,Nishinagae,Toyama, Toyama, Japan, 930-8550 | |
| Wakayama Medical University, School of Medicine | |
| 811-1,Kimiidera,Wakayama, Wakayama, Japan, 641-8510 | |
| Yamagata Prefectural Central Hospital | |
| 1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292 | |
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Mitsuru Sasako, MD, PhD | Hyogo College of Medicine |
More Information
Additional Information:
Publications:
| Responsible Party: | Mitsuru Sasako, MD, PhD, Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00112099 History of Changes |
| Other Study ID Numbers: | JCOG 0110, C000000004 |
| Study First Received: | May 27, 2005 |
| Last Updated: | August 2, 2009 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
gastric neoplasm gastrectomy splenectomy randomized trial T2, T3 and T4 carcinoma in the proximal third of the stomach |
Additional relevant MeSH terms:
|
Neoplasms Carcinoma Stomach Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Gastrointestinal Neoplasms |
Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |
ClinicalTrials.gov processed this record on May 23, 2013