Study of Micrometastases in Patients With Stage I or Stage II Localized Colon Cancer That Can Be Removed by Surgery

This is an interventional diagnostic trial for Colorectal Cancer focused on measuring stage I colon cancer, stage II colon cancer Read More

DISEASE CHARACTERISTICS:

• Histologically or radiologically confirmed primary colon cancer

  • Stage I or II disease
• Clinically localized disease judged potentially resectable for cure, without intraoperatively gross nodal involvement
• Planning to undergo elective resection of the tumor
• No histologically or radiologically confirmed locoregional lymph node or distant metastasis
• No disseminated disease
• No clinical tumor perforation or obstruction

• Patients enrolled in stage 2 and undergoing randomization must also meet the following criteria:

  • pN0micro+ disease as evidenced by detection of sentinel lymph node isolated tumor cells (<0.2 mm) or micrometastasis (0.2 - 2 mm)

  • No high-risk pN0 disease meeting any of the following criteria:

    • Less then 10 lymph nodes detected in resected specimen
    • Invasion in other organs (T4, Nx, Mx)
    • Colon perforation at presentation
    • Obstruction at presentation
    • Angioinvasion at pathological examination
  • No rectal cancer
  • No clinically positive nodal tumors or advanced disease (stage III or Dukes stage C disease)

PATIENT CHARACTERISTICS:

• Patients enrolled in stage 2 and undergoing randomization must also meet the following criteria:

  • WHO performance status 0-1 or American Society of Anesthesiologists Physical Status classification 1-2
  • Not pregnant or nursing
  • Able to comply with requirements of the study
  • Must be fit to undergo chemotherapy treatment

  • No other current serious illness or medical conditions, including any of the following:

    • Severe cardiac illness (NYHA class III-IV disease)
    • Significant neurologic or psychiatric disorders
    • Uncontrolled infections
    • Active disseminated intravascular coagulation
    • Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
  • No known hypersensitivity to study drugs
  • No definite contraindications for the use of corticosteroids

PRIOR CONCURRENT THERAPY:

• No prior colorectal surgery

• Patients enrolled in stage 2 and undergoing randomization must also meet the following criteria:

  • No prior chemotherapy (for patients enrolled in stage 2 and undergoing randomization only)
  • At least 4 weeks since prior and no other concurrent experimental drugs
  • No concurrent immunosuppressive or antiviral drugs