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Mesorectal Excision (ME) Versus ME With Lateral Node Dissection for Stage II, III Lower Rectal Cancer (JCOG0212)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Japan Clinical Oncology Group
Sponsor:
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
  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:

  1. Histologically confirmed adenocarcinoma
  2. Clinical stage II or III
  3. 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)
  4. Patient age is more than 20 and less than 75
  5. PS: 0, 1
  6. No past history of chemotherapy, pelvic surgery or radiation
  7. Written informed consent

    Operative criteria:

  8. Mesorectal excision is performed
  9. Operative findings:

    • Main lesion of the tumor is located at the rectum
    • Lower tumor margin is below the peritoneal reflection
  10. R0 after resection

Exclusion Criteria:

  1. Multiple cancer patients
  2. Pregnant patients
  3. Psychological disorder
  4. Steroid administration
  5. Cardiac infarction within six months
  6. Severe pulmonary emphysema and pulmonary fibrosis
  7. Doctor's decision for exclusion
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Rectal Neoplasms
Colorectal Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on November 27, 2014