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

Sponsors and Collaborators:	Japan Clinical Oncology Group Japanese Ministry of Health, Labor and Welfare
Information provided by:	Japan Clinical Oncology Group
ClinicalTrials.gov Identifier:	NCT00190541

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 III

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Mesorectal Excision With Lateral Lymph Node Dissection Versus Without Lateral Lymph Node Dissection for Clinical Stage II, III Lower Rectal Cancer (JCOG0212)

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:	600
Study Start Date:	June 2003
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Procedure/Surgery: Mesorectal excision with lateral lymph node dissection	Procedure: Mesorectal excision with lateral lymph node dissection
2: Experimental Procedure/Surgery: Mesorectal excision without lateral lymph node excision	Procedure: 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

Show 48 Study Locations

Sponsors and Collaborators

Japan Clinical Oncology Group

Japanese Ministry of Health, Labor and Welfare

Investigators

Study Chair:

Shin Fujita, MD

National Cancer Center Hospital

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Japan Clinical Oncology Group ( Shin Fujita, MD )
Study ID Numbers:	JCOG0212, C000000034
Study First Received:	September 13, 2005
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00190541
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

Study placed in the following topic categories:

Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Rectal Neoplasms
Gastrointestinal Neoplasms
Intestinal Diseases

Rectal cancer
Rectal Diseases
Intestinal Neoplasms
Colorectal Neoplasms
Rectal neoplasm

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009