A Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00147134 |
Recruitment Status :
Completed
First Posted : September 7, 2005
Last Update Posted : September 22, 2016
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Colorectal Cancer | Procedure: open colectomy Procedure: laparoscopic colectomy | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1050 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Randomized Controlled Trial to Evaluate Laparoscopic Versus Open Surgery for Colorectal Cancer(JCOG 0404,CRC Surg-LAP/OPEN) |
Study Start Date : | November 2004 |
Actual Primary Completion Date : | March 2014 |
Actual Study Completion Date : | March 2014 |
Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Procedure/Surgery: open colectomy
|
Procedure: open colectomy
Procedure/Surgery: open colectomy |
Experimental: 2
Procedure/Surgery: laparoscopic colectomy
|
Procedure: laparoscopic colectomy
Procedure/Surgery: laparoscopic colectomy |
- Overall survival [ Time Frame: During the study conduct ]
- Relapse-free survival [ Time Frame: During the study conduct ]
- Short-term clinical outcomes [ Time Frame: time to 1st discharge after operation ]
- Adverse events [ Time Frame: During the study conduct ]
- The proportion of conversion from LAP to OPEN [ Time Frame: operation day ]
- The proportion of completion of LAP [ Time Frame: operation day ]
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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Histologically proven colorectal carcinoma
- Tumor located in the cecum, ascending colon, sigmoid colon, or rectosigmoid colon
- T3 or deeper lesion without involvement of other organs
- Without multiple lesion other than carcinoma in situ
- Cancer classified as N0-2 and M0, according to the TNM classification system
- Tumor size < 8 cm
- No bowel obstruction
- Age 20 < and > 75 years
- Sufficient organ function
- No history of gastrointestinal surgery
- No history of chemotherapy or radiotherapy
- Provided written informed consent
Exclusion Criteria:
- Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
- Severe pulmonary emphysema, interstitial pneumonitis, or ischemic heart disease
- Pregnant or lactating women
- Severe mental disease
- Continuous systemic steroid therapy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00147134
Study Chair: | Seigo Kitano, MD, PhD,FACS | Oita University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Haruhiko Fukuda, JCOG Data Center, Japan Clinical Oncology Group |
ClinicalTrials.gov Identifier: | NCT00147134 |
Other Study ID Numbers: |
JCOG0404 C000000105 |
First Posted: | September 7, 2005 Key Record Dates |
Last Update Posted: | September 22, 2016 |
Last Verified: | September 2016 |
colorectal cancer laparoscopic surgery randomized controlled trial oncological outcome |
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |