Patient case: 45-year-old female with colon cancer; genetic feature: PIK3CA (E545K)

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

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.

Eligibility: 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

Relevance to patient case: not relevant