A Trial of Neoadjuvant TS-1 and Cisplatin for Type 4 and Large Type 3 Gastric Cancer
This study is currently recruiting participants.
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
Japan Clinical Oncology Group
Collaborator:
Ministry of Health, Labour and Welfare, Japan
Information provided by:
Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:
NCT00252161
First received: November 10, 2005
Last updated: June 13, 2010
Last verified: June 2010
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Purpose
The aim of this study is to evaluate survival benefit of TS-1 plus cisplatin as a neoadjuvant chemotherapy in gastric cancer patient with resectable type 4 (linitis plastica type) and large type 3 tumor in comparison with surgery alone.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastric Neoplasm |
Procedure: Gastrectomy with more than D2 dissection Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Phase III Trial of Surgery Plus Neoadjuvant TS-1 and Cisplatin Compared With Surgery Alone for Type 4 and Large Type 3 Gastric Cancer: Japan Clinical Oncology Group Study (JCOG 0501) |
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:
- progression free survival (PFS) [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- response rate [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- proportion of protocol achievement [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- proportion of curative resection [ Time Frame: during the study conduct ] [ Designated as safety issue: No ]
- adverse events [ Time Frame: during the study conduct ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 316 |
| Study Start Date: | November 2005 |
| Estimated Study Completion Date: | April 2015 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Procedure/Surgery: Gastrectomy with more than D2 dissection
|
Procedure: Gastrectomy with more than D2 dissection
Gastrectomy with more than D2 dissection
|
|
Experimental: 2
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
|
Drug: Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
Neoadjuvant chemotherapy(TS-1+CDDP) followed by gastrectomy
|
Detailed Description:
A randomized phase III study is going to started in Japan to compare TS-1 plus cisplatin as a neoadjuvant chemotherapy with surgery alone in patient with type 4 and large type 3 gastric cancer.A total of 300 patients will be accrued for this study from 35 institutions within five years. The primary endpoint is overall survival. The secondary endpoints are progression free survival (PFS), response rate, proportion of protocol achievement, proportion of curative resection, and adverse events.
Eligibility| Ages Eligible for Study: | 20 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- histologically proven adenocarcinoma of stomach
- Borrmann type 4 or large (>=8 cm) type 3
- no evidence of distant metastasis including liver(M0)
- no evidence of para-aortic and/or retropancreatic lymph node metastasis(N0-2)
- no peritoneal metastasis and negative peritoneal lavage cytology (PLS) with laparoscopic confirmation
- no involvement of the esophagus with > 3cm
- an age of 20-75 years
- an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
- no prior chemotherapy, radiotherapy for any malignancy
- no prior surgery for gastric cancer except for endoscopic membrane resection (EMR)
- no breeding from primary tumor or gastrointestinal stenosis
- sufficient oral intake
- adequate organ function
- written informed consent
Exclusion Criteria:
- synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- pregnant or breast-feeding women
- severe mental disease
- systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
- other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
- myocardial infarction within six disease-free months
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252161
Contacts
| Contact: Yoshiaki Iwasaki, MD, PhD | 81-3-3823-2101 | JCOG_sir@ml.jcog.jp |
| Contact: Kuniyoshi Arai, MD, PhD | 81-3-3823-2101 | JCOG_sir@ml.jcog.jp |
Locations
| Japan | |
| Aichi Cancer Center Hospital | Recruiting |
| 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681 | |
| Contact: Seiji Itoh, M.D. 81-52-762-6111 | |
| Fujita Health University | Recruiting |
| 1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan, 470-1192 | |
| Contact: Ichiro Uyama, M.D.,Ph.D. 81-562-93-9254 | |
| National Cancer Center Hospital East | Recruiting |
| 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577 | |
| Contact: Taira Kinoshita, M.D. 81-471-33-1111 | |
| National Hospital Organization Shikoku Cancer Center | Recruiting |
| 13,Horinouchi,Matsuyama, Ehime, Japan, 790-0007 | |
| Contact: Yoshiro Kubo, M.D., Ph.D. 81-89-932-1111 | |
| Gifu Municipal Hospital | Recruiting |
| 7-1,Kashima-cho,Gifu, Gifu, Japan, 500-8323 | |
| Contact: Hiroo Ohshita, M.D. 81-58-251-1101 | |
| Hiroshima City Hospital | Recruiting |
| 7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan, 730-8518 | |
| Contact: Masahiko Nishizaki, M.D., Ph.D. 81-82-221-2291 | |
| Itami City Hospital | Recruiting |
| 1-100,Koyaike,Itami, Hyogo, Japan, 664-8540 | |
| Contact: Masahiro Hiratsuka, M.D., Ph.D. 81-72-777-3773 | |
| Iwate Medical University | Recruiting |
| 19-1,Uchimaru,Morioka, Iwate, Japan, 020-8505 | |
| Contact: Takagane Akinori, M.D., Ph.D. 81-19-651-5111 | |
| Kagoshima University,Faculty of Medicine | Recruiting |
| 8-35-1,Sakuragaoka,Kagoshima, Kagoshima, Japan, 890-8520 | |
| Contact: Akihiro Nakajoh, M.D. 81-99-275-5361 | |
| Kanagawa Cancer Center | Recruiting |
| 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815 | |
| Contact: Takaki Yoshikawa, M.D., Ph.D. 81-45-391-5761 | |
| Kyoto Second Red Cross Hospital | Recruiting |
| 355-5,Kamanza-Marutamachi,Kamigyo-ku, Kyoto, Japan, 602-8026 | |
| Contact: Masataka Shimotsuma, M.D., Ph.D. 81-75-231-5171 | |
| National Hospital Organization, Sendai Medical Center | Recruiting |
| 2-8-8,Miyagino,Miyagino-ku,Sendai, Miyagi, Japan, 983-8520 | |
| Contact: Shin Teshima, M.D. 81-22-293-1111 | |
| Miyagi Cancer Center | Recruiting |
| 47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293 | |
| Contact: Hideaki Yamanami, M.D.,Ph.D. 81-22-384-3151 | |
| Niigata Cancer Center Hospital | Recruiting |
| 2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566 | |
| Contact: Hiroshi Yabusaki, M.D. 81-25-266-5111 | |
| Nagaoka Chuo General Hospital | Recruiting |
| 2041,Kawasaki,Nagaoka, Niigata, Japan, 940-8653 | |
| Contact: Yasuyuki Kawachi, M.D. 81-258-35-3700 | |
| Tsubame Rosai Hospital | Recruiting |
| 633,Sawatari,Tsubame, Niigata, Japan, 959-1228 | |
| Contact: Kikuo Aizawa, M.D. 81-256-64-5111 | |
| Oita University Fuculty of Medicine | Recruiting |
| 1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan, 879-5593 | |
| Contact: Norio Shiraishi, M.D. 81-97-586-5843 | |
| Sakai Municipal Hospital | Recruiting |
| 1-1-1,Minamiyasuicho,Sakai, Osaka, Japan, 590-0064 | |
| Contact: Hiroshi Imamura, M.D., Ph.D. 81-72-221-1700 | |
| Osaka Medical Center for Cancer and Cardiovascular Diseases | Recruiting |
| 1-3-3,Nakamichi,Higashinari-ku,Osaka, Osaka, Japan, 537-8511 | |
| Contact: Isao Miyashiro, M.D., Ph.D. 81-6-6972-1181 | |
| Osaka National Hospital | Recruiting |
| 2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006 | |
| Contact: Motohiro Hirao, M.D. 81-6-6942-1331 | |
| Osaka Medical College | Recruiting |
| 2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801 | |
| Contact: Eiji Nomura, M.D. 81-72-683-1221 | |
| Kinki University School of Medicine | Recruiting |
| 377-2,Ohno-higashi,Osaka-Sayama, Osaka, Japan, 589-8511 | |
| Contact: Hironori Shigeoka, M.D., Ph.D. 81-72-366-0221 | |
| Toyonaka Municipal Hospital | Recruiting |
| 4-14-1,Shibaharacho,Toyonaka, Osaka, Japan, 560-0055 | |
| Contact: Junya Fujita, M.D. 81-6-6843-0101 | |
| National Defense Medical College | Recruiting |
| 3-2,Namiki,Tokorozawa, Saitama, Japan, 359-8513 | |
| Contact: Takashi Ichikura, M.D. 81-4-2995-1637 | |
| Saitama Cancer Center | Recruiting |
| 818,Komuro,Ina,Kita-adachi, Saitama, Japan, 362-0806 | |
| Contact: Yoshiyuki Kawashima, M.D. 81-48-722-1111 | |
| Shizuoka General Hospital | Recruiting |
| 4-27-1,Kitaando,Aoi-ku,Shizuoka, Sizuoka, Japan, 420-8527 | |
| Contact: Masakazu Takagi, M.D. 81-54-247-6111 | |
| International Medical Center of Japan | Recruiting |
| 1-21-1,Toyama,Shinjuku-ku, Tokyo, Japan, 162-8655 | |
| Contact: Toshio Shimizu, M.D. 81-3-3202-7181 | |
| Tokyo Medical and Dental University Hospital | Recruiting |
| 1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Contact: Kazuyuki Kojima, M.D. 81-3-5803-5261 | |
| Cancer Institute Hospital | Recruiting |
| 3-10-6,Ariake,Koto-ku, Tokyo, Japan, 135-8550 | |
| Contact: Yasuyuki Seto, M.D., Ph.D. 81-3-3520-0111 | |
| Tokyo Metropolitan Komagome Hospital | Recruiting |
| 3-18-22,Honkomagome,Bunkyo-ku, Tokyo, Japan, 113-8677 | |
| Contact: Yoshiaki Iwasaki, M.D. 81-3-3823-2101 | |
| Tokyo Metropolitan Bokutoh Hospital | Recruiting |
| 4-23-15,Koutoubashi,Sumida-ku, Tokyo, Japan, 130-8575 | |
| Contact: Satoru Inoue, M.D. 81-3-3633-6151 | |
| National Cancer Center Hospital | Recruiting |
| 5-1-1,Tsukiji,Chuo-ku, Tokyo, Japan, 104-0045 | |
| Contact: Takeshi Sano 81-3-3542-2511 | |
| Toyama Prefectural Central Hospital | Recruiting |
| 2-2-78,nishinagae,Toyama, Toyama, Japan, 930-8550 | |
| Contact: Masahide Kaji, M.D., Ph.D. 81-76-424-1531 | |
| Wakayama Medical University, School of Medicine | Recruiting |
| 811-1,Kimiidera,Wakayama, Wakayama, Japan, 641-8510 | |
| Contact: Makoto Iwahashi, M.D., Ph.D. 81-73-441-0612 | |
| Yamagata Prefectural Central Hospital | Recruiting |
| 1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292 | |
| Contact: Norimasa Fukushima, M.D. 81-23-685-2626 | |
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:
No publications provided
| Responsible Party: | Mitsuru Sasako, MD, PhD, Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00252161 History of Changes |
| Other Study ID Numbers: | JCOG0501, C000000279 |
| Study First Received: | November 10, 2005 |
| Last Updated: | June 13, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
Neoadjuvant Therapy Stomach Neoplasms Cisplatin S-1(combination) |
Additional relevant MeSH terms:
|
Neoplasms Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases |
Stomach Diseases Cisplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 17, 2013