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

Phase 3

Completed

• Conditions: Rectal Neoplasms

• Registration Number: NCT00190541
• Lead Sponsor: Haruhiko Fukuda

Brief Summary

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

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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-20
• Last Update Posted: 2016-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Relapse-free survival	Until relapsing

Secondary Outcome Measures

Name	Time	Method
Local-recurrence-free survival	Until local-recurrence
Incidence of adverse events	5 years
Incidence of major adverse events	5 years
Operative time	Operation day
Blood loss	Operation day
Incidence of sexual and urinary dysfunction	1 year
Overall survival	Overall

Trial Locations

Locations (48)

Aichi Cancer Center Hospital; 🇯🇵 Nagoya,Chikusa-ku,Kanokoden,1-1, Aichi, Japan

Fujita Health University; 🇯🇵 Toyoake,Kutsukake-cho,Dengakugakubo,1-98, Aichi, Japan

Chiba Cancer Center Hospital; 🇯🇵 Chiba,Chuo-ku,Nitona-cho,666-2, Chiba, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa,Kashiwanoha,6-5-1, Chiba, Japan

Toho University Sakura Hospital; 🇯🇵 Sakura,Shimoshidu,564-1, Chiba, Japan

Jyuntendo Urayasu Hospital; 🇯🇵 Urayasu,Tomioka,2-1-1, Chiba, Japan

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama,Horinouchi,13, Ehime, Japan

National Kyushu Cancer Center; 🇯🇵 Fukuoka,Minami-ku,Notame,3-1-1, Fukuoka, Japan

Kurume University School of Medicine; 🇯🇵 Kurume,Asahi-machi,67, Fukuoka, Japan

Kurume University Medical Center; 🇯🇵 Kurume,Kokubumachi,155-1, Fukuoka, Japan

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