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NCT00002575 · CITED IN SOURCE DOCUMENTS

Laparoscopic-Assisted Surgery Compared With Open Surgery in Treating Patients With Colon Cancer

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2016-07-18

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

No posted result sections were captured. Registered plans do not establish that a treatment works.

Who could take part
eligibility Criteria
DISEASE CHARACTERISTICS: * Clinical diagnosis of primary adenocarcinoma * Involving a single colon segment: * Right colon from the ileocecal valve up to and including the hepatic flexure * Left colon from the splenic flexure to the junction of the sigmoid and descending colon * Sigmoid colon between the descending colon and the rectum (at least 15 cm from the dentate) * Diagnosis based on physical exam plus either a proctosigmoidoscopy and barium enema or a colonoscopy * No advanced local disease that renders laparoscopic resection impossible * No acutely obstructed or perforated colon cancer requiring urgent surgery * No transverse colon cancer (i.e., between distal hepatic flexure and proximal splenic flexure) * No stage IV disease * No rectal cancer (i.e., below the peritoneal reflection, lower edge of tumor less than 15 cm from dentate) * No American Society of Anesthesiologists IV/V disease classification * No associated gastrointestinal diseases (i.e., Crohn's, chronic ulcerative colitis, or familial polyposis) that require additional extensive operative evaluation or intervention PATIENT CHARACTERISTICS: Age: * 18 and over Other: * No other prior or concurrent malignancy within the past 5 years except superficial squamous cell or basal cell skin cancer or carcinoma in situ of the cervix * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Surgery: * No prohibitive scars/adhesions from prior abdominal surgery Other: * No concurrent investigational treatments or invasive diagnostic procedures within 30 days after surgery
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    intervention Names
    1. Procedure: conventional surgery
    label
    Conventional surgery
    type
    EXPERIMENTAL
  2. description
    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.
    intervention Names
    1. Procedure: laparoscopic surgery
    label
    Laparoscopic-assisted colectomy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Conventional surgery
    name
    conventional surgery
    type
    PROCEDURE
  2. arm Group Labels
    1. Laparoscopic-assisted colectomy
    name
    laparoscopic surgery
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
810
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    * 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)
    measure
    Disease-free survival
    time Frame
    Up to 8 years
  2. measure
    Overall survival
    time Frame
    Up to 8 years
secondary Outcomes
  1. measure
    Morbidity
    time Frame
    Up to 8 years
  2. measure
    Mortality
    time Frame
    At 30 days
  3. measure
    Costs and cost effectiveness between these treatments in this patient population
    time Frame
    Up to 8 years
  4. measure
    Compare the differences in quality of life of patients treated with these regimens
    time Frame
    Up to 8 years
Full study description
brief Summary
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.
detailed Description
OBJECTIVES: * 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) 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.
Source references
references
  1. citation
    Stucky CC, Pockaj BA, Novotny PJ, Sloan JA, Sargent DJ, O'Connell MJ, Beart RW, Skibber JM, Nelson H, Weeks JC. Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146). Ann Surg Oncol. 2011 Sep;18(9):2422-31. doi: 10.1245/s10434-011-1650-2. Epub 2011 Mar 31.
    pmid
    21452066
    type
    RESULT
  2. citation
    Larson DW, Marcello PW, Larach SW, Wexner SD, Park A, Marks J, Senagore AJ, Thorson AG, Young-Fadok TM, Green E, Sargent DJ, Nelson H. Surgeon volume does not predict outcomes in the setting of technical credentialing: results from a randomized trial in colon cancer. Ann Surg. 2008 Nov;248(5):746-50. doi: 10.1097/SLA.0b013e31818a157d.
    pmid
    18948801
    type
    RESULT
  3. citation
    Clinical Outcomes of Surgical Therapy Study Group; Nelson H, Sargent DJ, Wieand HS, Fleshman J, Anvari M, Stryker SJ, Beart RW Jr, Hellinger M, Flanagan R Jr, Peters W, Ota D. A comparison of laparoscopically assisted and open colectomy for colon cancer. N Engl J Med. 2004 May 13;350(20):2050-9. doi: 10.1056/NEJMoa032651.
    pmid
    15141043
    type
    RESULT
  4. citation
    Weeks JC, Nelson H, Gelber S, Sargent D, Schroeder G; Clinical Outcomes of Surgical Therapy (COST) Study Group. Short-term quality-of-life outcomes following laparoscopic-assisted colectomy vs open colectomy for colon cancer: a randomized trial. JAMA. 2002 Jan 16;287(3):321-8. doi: 10.1001/jama.287.3.321.
    pmid
    11790211
    type
    RESULT
Source notices and limitations
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    Preserved source evidence · Independent clinical review pending · Not medical advice