Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)
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:
NCT00190541
First received: September 13, 2005
Last updated: June 13, 2010
Last verified: June 2010
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Purpose
The purpose of this study is to evaluate the of international standard operation, mesorectal excision (ME alone) compared to Japanese standard operation, ME with lateral lymph node dissection for clinical stage II, III lower rectal cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Rectal Neoplasms |
Procedure: Mesorectal excision with lateral lymph node dissection Procedure: Mesorectal excision without lateral lymph node excision |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212) |
Resource links provided by NLM:
Further study details as provided by Japan Clinical Oncology Group:
Primary Outcome Measures:
- Relapse-free survival [ Time Frame: Until relapsing ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival [ Time Frame: Overall ] [ Designated as safety issue: No ]
- Local-recurrence-free survival [ Time Frame: Until local-recurrence ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Incidence of major adverse events [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- Operative time [ Time Frame: Operation day ] [ Designated as safety issue: Yes ]
- Blood loss [ Time Frame: Operation day ] [ Designated as safety issue: Yes ]
- Incidence of sexual and urinary dysfunction [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 700 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Procedure/Surgery: Mesorectal excision with lateral lymph node dissection
|
Procedure: Mesorectal excision with lateral lymph node dissection
Mesorectal excision with lateral lymph node dissection
|
|
Experimental: 2
Procedure/Surgery: Mesorectal excision without lateral lymph node excision
|
Procedure: Mesorectal excision without lateral lymph node excision
Mesorectal excision without lateral lymph node excision
|
Detailed Description:
Total mesorectal excision (TME) or mesorectal excision (ME) with lateral lymph node dissection for advanced rectal cancer is widely performed in Japan. In other countries, TME or ME without lateral lymph node dissection is the standard. In order to determine which is the better rectal cancer surgery, relapse-free survivals of these are compared as the primary endpoint.
Eligibility| Ages Eligible for Study: | 21 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Preoperative criteria:
- Histologically confirmed adenocarcinoma
- Clinical stage II or III
Preoperative findings:
- Main lesion of the tumor is located at the rectum
- Lower tumor margin is below the peritoneal reflection
- No extramesorectal lymph node swelling (Shorter diameter is less than 10 mm)
- No invasion to other organ (s)
- Patient age is more than 20 and less than 75
- PS: 0, 1
- No past history of chemotherapy, pelvic surgery or radiation
Written informed consent
Operative criteria:
- Mesorectal excision is performed
Operative findings:
- Main lesion of the tumor is located at the rectum
- Lower tumor margin is below the peritoneal reflection
- R0 after resection
Exclusion Criteria:
- Multiple cancer patients
- Pregnant patients
- Psychological disorder
- Steroid administration
- Cardiac infarction within six months
- Severe pulmonary emphysema and pulmonary fibrosis
- Doctor's decision for exclusion
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00190541
Contacts
| Contact: Shin Fujita, MD | 81-3-3542-2511 | JCOG_sir@ml.jcog.jp |
| Contact: Takayuki Akasu, MD | 81-3-3542-2511 | JCOG_sir@ml.jcog.jp |
Locations
| Japan | |
| Aichi Cancer Center Hospital | Recruiting |
| 1-1,Kanokoden,Chikusa-ku,Nagoya, Aichi, Japan, 464-8681 | |
| Contact: Yukihide Kanemitsu, M.D. 81-52-762-6111 | |
| Fujita Health University | Recruiting |
| 1-98,Dengakugakubo,Kutsukake-cho,Toyoake, Aichi, Japan, 470-1192 | |
| Contact: Harunobu Sato, M.D., Ph.D. 81-562-93-9296 | |
| Jyuntendo Urayasu Hospital | Recruiting |
| 2-1-1,Tomioka,Urayasu, Chiba, Japan, 279-0021 | |
| Contact: Kunihiko Nagakari, M.D. 81-47-353-3111 | |
| Toho University Sakura Hospital | Recruiting |
| 564-1,Shimoshidu,Sakura, Chiba, Japan, 285-8741 | |
| Contact: Juri Kondo, M.D. 81-43-462-8811 | |
| National Cancer Center Hospital East | Recruiting |
| 6-5-1,Kashiwanoha,Kashiwa, Chiba, Japan, 277-8577 | |
| Contact: Masanori Sugito, M.D. 81-471-33-1111 | |
| Chiba Cancer Center Hospital | Recruiting |
| 666-2,Nitona-cho,Chuo-ku,Chiba, Chiba, Japan, 260-8717 | |
| Contact: Hiroaki Soda, M.D., Ph.D. 81-43-264-5431 | |
| 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 | |
| Kurume University Medical Center | Recruiting |
| 155-1,Kokubumachi,Kurume, Fukuoka, Japan, 839-0863 | |
| Contact: Yoshito Akagi, M.D. 81-942-22-6111 | |
| National Kyushu Cancer Center | Recruiting |
| 3-1-1,Notame,Minami-ku,Fukuoka, Fukuoka, Japan, 811-1395 | |
| Contact: Yasushi Toh, M.D., Ph.D. 81-92-541-3231 | |
| Kurume University School of Medicine | Recruiting |
| 67,Asahi-machi,Kurume, Fukuoka, Japan, 830-0011 | |
| Contact: Yutaka Ogata, M.D., Ph.D. 81-942-35-3311 | |
| Gunma Prefectural Cancer Center | Recruiting |
| 617-1,Takabayashi-nishi-cho,Ota, Gunma, Japan, 373-8550 | |
| Contact: Shinichi Sameshima, M.D. 81-276-38-0771 | |
| Hiroshima University, School of Medicine | Recruiting |
| 1-2-3,Kasumi,Minami-ku,Hiroshima, Hiroshima, Japan, 734-8551 | |
| Contact: Satoshi Ikeda, M.D., Ph.D. 81-82-257-5222 | |
| Hiroshima City Hospital | Recruiting |
| 7-33,Motomachi,Naka-ku,Hiroshima, Hiroshima, Japan, 730-8518 | |
| Contact: Tadashi Onoda, M.D. 81-82-221-2291 | |
| Sapporo-Kosei General Hospital | Recruiting |
| North-3,East8-5,Chuou-ku,Sapporo, Hokkaido, Japan, 060-0033 | |
| Contact: Hiroyuki Masuko, M.D. 81-11-261-5331 | |
| Kansai Rosai Hospital | Recruiting |
| 3-1-69,Inabasou,Amagasaki, Hyogo, Japan, 660-8511 | |
| Contact: Shu Okamura, M.D., Ph.D. 81-6-6416-1221 | |
| Ibaraki Kenritsu Chuo Hospital & Cancer Center | Recruiting |
| 6528 Koibuchi,Tomobemachi,Nishi-ibarakigun, Ibaraki, Japan, 309-1793 | |
| Contact: Kojun Okamoto, M.D., Ph.D. 81-296-77-1121 | |
| Ishikawa Prefectual Central Hospital | Recruiting |
| 2-1,Kuratsuki-Higashi,Kanazawa, Ishikawa, Japan, 920-8530 | |
| Contact: Hiroyuki Bando, M.D. 81-76-237-8211 | |
| Kanagawa Cancer Center | Recruiting |
| 1-1-2,Nakao,Asahi-ku,Yokohama, Kanagawa, Japan, 241-0815 | |
| Contact: Makoto Akaike, M.D. 81-45-391-5761 | |
| Kitasato University School of Medichine | Recruiting |
| 1-15-1,Kitasato,Sagamihara, Kanagawa, Japan, 228-8555 | |
| Contact: Takatoshi Nakamura, M.D. 81-42-778-8111 | |
| Kitasato University East Hospital | Recruiting |
| 2-1-1,Asamizodai,Sagamihara, Kanagawa, Japan, 228-8520 | |
| Contact: Takeo Satoh, M.D. 81-42-748-9111 | |
| Teikyo University Hospital, Mizonokuchi | Recruiting |
| 3-8-3,Mizonokuchi,Takatsu-ku,Kawasaki, Kanagawa, Japan, 213-8507 | |
| Contact: Tadashi Suda, M.D. 81-44-844-3223 | |
| Showa University Northern Yokohama Hospital | Recruiting |
| 35-1,Chigasakichuo,Tsuzuki-ku,Yokohama, Kanagawa, Japan, 224-8503 | |
| Contact: Jun-ichi Tanaka, M.D., Ph.D. 81-45-949-7763 | |
| Yokohama City University Medical Center | Recruiting |
| 4-57,Urafunecho,Minami-ku,Yokohama, Kanagawa, Japan, 232-0024 | |
| Contact: Shigeru Yamagishi, M.D., Ph.D. 81-45-261-5656 | |
| National Hospital Organization Kyoto Medical Center | Recruiting |
| 1-1,Mukaihata-cho,Fukakusa,Fushimi-ku,Kyoto, Kyoto, Japan, 612-8555 | |
| Contact: Takashi Yamaguchi, M.D. 81-75-645-8405 | |
| Miyagi Cancer Center | Recruiting |
| 47-1,Nodayama,Medeshima-Shiode,Natori, Miyagi, Japan, 981-1293 | |
| Contact: Masayuki Satoh, M.D. 81-22-384-3151 | |
| Nagano Municipal Hospital | Recruiting |
| 1333-1,Tomitake,Nagano, Nagano, Japan, 381-8551 | |
| Contact: Takehito Yamabe, RPh. 81-26-295-1199 | |
| Niigata Cancer Center Hospital | Recruiting |
| 2-15-3,Kawagishi-cho,Niigata, Niigata, Japan, 951-8566 | |
| Contact: Yasumasa Takii, M.D. 81-25-266-5111 | |
| Oita University Fuculty of Medicine | Recruiting |
| 1-1,Oogaoka,Hasama-machi,Oita, Oita, Japan, 879-5593 | |
| Contact: Masafumi Inomata, M.D. 81-97-586-5843 | |
| Okayama Saiseikai General Hospital | Recruiting |
| 1-17-18,Ifukucho,Okayama, Okayama, Japan, 700-8511 | |
| Contact: Yasuki Nitta, M.D. 81-86-252-2211 | |
| Sakai Municipal Hospital | Recruiting |
| 1-1-1,Minamiyasuicho,Sakai, Osaka, Japan, 590-0064 | |
| Contact: Hiroyoshi Takemoto, 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: Shingo Noura, M.D., Ph.D. 81-6-6972-1181 | |
| Osaka National Hospital | Recruiting |
| 2-1-14,Hoenzaka,Chuo-ku,Osaka, Osaka, Japan, 540-0006 | |
| Contact: Masakazu Ikenaga, M.D., Ph.D. 81-6-6942-1331 | |
| Osaka City General Hospital | Recruiting |
| 2-13-22,Miyakojimahondori,Miyakojima-ku,Osaka, Osaka, Japan, 534-0021 | |
| Contact: Yosuke Fukunaga, M.D, Ph.D. 81-6-6929-1221 | |
| Osaka University Graduate School of Medicine | Recruiting |
| 2-2,Yamada-oka,Suita, Osaka, Japan, 565-0871 | |
| Contact: Mitsugu Sekimoto, M.D. 81-6-6879-3251 | |
| Osaka Medical College | Recruiting |
| 2-7,Daigakucho,Takatsuki, Osaka, Japan, 569-0801 | |
| Contact: Junji Okuda, M.D. 81-72-683-1221 | |
| Minoh City Hospital | Recruiting |
| 5-7-1,Kayano,Minoh, Osaka, Japan, 562-8562 | |
| Contact: Takeshi Kato, M.D., Ph.D. 81-72-728-2001 | |
| Omiya Medical Center, Jichi Medical School | Recruiting |
| 1-847,Amanuma-cho,Omiya-ku,Saitama, Saitama, Japan, 330-8503 | |
| Contact: Yutaka Kawamura, M.D., Ph.D. 81-48-647-2111 | |
| National Defense Medical College | Recruiting |
| 3-2,Namiki,Tokorozawa, Saitama, Japan, 359-8513 | |
| Contact: Yojiro Hashiguchi, M.D. 81-42-995-1211 | |
| Sizuoka Cancer Center | Recruiting |
| 1007,Shimonagakubo,Nagaizumi-cho,Sunto-gun, Shizuoka, Japan, 411-8777 | |
| Contact: Shuji Saito, M.D. 81-55-989-5222 | |
| Tochigi Cancer Center | Recruiting |
| 4-9-13,Yohnan,Utsunomiya, Tochigi, Japan, 320-0834 | |
| Contact: Hirofumi Fujii, M.D., Ph.D. 81-28-658-5151 | |
| Tokyo Medical and Dental University Hospital | Recruiting |
| 1-5-45,Yushima,Bunkyo-ku, Tokyo, Japan, 113-8519 | |
| Contact: Hiroyuki Uetake, M.D. 81-3-5803-5261 | |
| Toho University Ohashi Hospital | Recruiting |
| 2-17-6,Ohashi,Meguro-ku, Tokyo, Japan, 153-0044 | |
| Contact: Yoshihisa Saida, M.D., Ph.D. 81-3-3468-1251 | |
| Toranomon Hospital | Recruiting |
| 2-2-2,Toranomon,Minato-ku, Tokyo, Japan, 105-8470 | |
| Contact: Toshihito Sawada, M.D. 81-3-3588-1111 | |
| Keio University Hospital | Recruiting |
| 35,Shinanomachi,Shinjuku-ku, Tokyo, Japan, 160-8582 | |
| Contact: Hideki Nishibori, M.D., Ph.D. 81-3-3353-1211 | |
| National Cancer Center Hospital | Recruiting |
| 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan, 104-0045 | |
| Contact: Yasuhiro Shimada, MD 81-3-3542-2511 | |
| Kyorin University School of Medicine | Recruiting |
| 6-20-2,Shinkawa,Mitaka, Tokyo, Japan, 181-8611 | |
| Contact: Hiroyoshi Matsuoka, M.D. 81-422-47-5511 | |
| Tokyo Medical University | Recruiting |
| 6-7-1,Nishi-shinjuku,Shinjuku-ku, Tokyo, Japan, 160-0023 | |
| Contact: Kenji Katsumata, M.D. 81-3-3342-6111 | |
| Yamagata Prefectural Central Hospital | Recruiting |
| 1800,Aoyagi,Yamagata, Yamagata, Japan, 990-2292 | |
| Contact: Toshihiko Sato, M.D. 81-23-685-2626 | |
Sponsors and Collaborators
Japan Clinical Oncology Group
Ministry of Health, Labour and Welfare, Japan
Investigators
| Study Chair: | Shin Fujita, MD | National Cancer Center Hospital |
More Information
Additional Information:
No publications provided by Japan Clinical Oncology Group
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Shin Fujita, MD, Japan Clinical Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00190541 History of Changes |
| Other Study ID Numbers: | JCOG0212, C000000034 |
| Study First Received: | September 13, 2005 |
| Last Updated: | June 13, 2010 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Japan Clinical Oncology Group:
|
Rectal Cancer Lymph Node Dissection Rectal Surgery Autonomic Nerves Stage II, III lower rectal cancer |
Additional relevant MeSH terms:
|
Neoplasms Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms |
Neoplasms by Site Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 16, 2013