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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Diagnostic procedures such as sentinel lymph node mapping may help doctors find patients who are at risk of developing micrometastases and plan better treatment.

PURPOSE: This randomized phase II/III trial is studying micrometastases in patients with stage I or stage II localized colon cancer that can be removed by surgery.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeroen Bosch Ziekenhuis
• Treatments: Capecitabine; Oxaliplatin

Criteria

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