A Phase 3 interventional study of conventional surgery and laparoscopic surgery in Colorectal Cancer, sponsored by Alliance for Clinical Trials in Oncology. Completed at 158 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-07-18.
Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Treatment
RATIONALE: Less invasive types of surgery may help reduce the number of side effects and improve recovery. It is not yet known which type of surgery is more effective for colon cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of laparoscopic-assisted colectomy with open colectomy in treating patients who have colon cancer.
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, primary surgeon, site of primary tumor (right vs left vs sigmoid), and American Society of Anesthesiologists disease classification (I and II vs III). Patients are randomized to one of two treatment arms.
The extent of colon resection is identical for both arms.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 810 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Clinical diagnosis of primary adenocarcinoma
Involving a single colon segment:
PATIENT CHARACTERISTICS:
Age:
Other:
PRIOR CONCURRENT THERAPY:
Surgery:
Other:
Patients undergo open laparotomy and colectomy. A standard incision is made through the abdominal wall and the abdominal cavity is explored. A right or left colectomy or a sigmoid resection is performed. Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms. Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99) Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
Procedure: conventional surgery
Patients undergo a laparoscopic-assisted colectomy. A small infraumbilical incision is made through the abdominal skin and the abdominal cavity is insufflated with CO2 to allow access and visualization. The abdominal cavity is explored. If advanced local disease is identified, a celiotomy and colectomy are performed. Otherwise, a right or left colectomy or sigmoid resection is performed using laparoscopic-assisted techniques. Patients may be entered on adjuvant chemotherapy trials after surgery provided the subsequent trial does not include radiotherapy and allows entry of patients from both arms. Quality of life is assessed at baseline and on days 2 and 14 after surgery, at 2 months, and then at 18 months. (closed as of 4/30/99) Patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 3 years.
Procedure: laparoscopic surgery
Disease-free survival
* Compare the disease-free and overall survival rates of patients with colon cancer treated with laparoscopic-assisted colectomy vs open colectomy. * Compare the safety of these regimens in terms of early and late morbidity and 30-day mortality of these patients. * Compare the differences in costs and cost effectiveness between these treatments in this patient population. * Compare the differences in quality of life of patients treated with these regimens. (closed as of 4/30/99)
Time frame: Up to 8 years
Overall survival
Time frame: Up to 8 years
Morbidity
Time frame: Up to 8 years
Mortality
Time frame: At 30 days
Costs and cost effectiveness between these treatments in this patient population
Time frame: Up to 8 years
Compare the differences in quality of life of patients treated with these regimens
Time frame: Up to 8 years
Showing the first 100 of 158 sites across 3 countries.
This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.
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Alliance for Clinical Trials in Oncology