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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study

Brief 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.


Detailed Summary:

OBJECTIVES:

  • To determine the subset of patients with stage I or II localized, resectable colon cancer (pN0) at risk for developing systemic metastases.
  • To determine the clinical and prognostic relevance of occult nodal isolated tumor cells and micrometastases in these patients.
  • To determine the benefits of adjuvant chemotherapy in patients with pN0micro+ colon cancer.

OUTLINE: This is a phase II feasibility study (stage 1) followed by a phase III multicenter, open-label, randomized, and controlled study (stage 2).

  • Stage 1 (phase II feasibility study) After undergoing planned curative resection followed by ex vivo sentinel lymph node mapping (SLNM). Resected samples are examined. The sentinel lymph nodes of those deemed pN0 disease (no macroscopic metastases or angioinvasion) are further evaluated for micrometastases by serial sectioning and immunohistochemistry using pan-cytokeratin. pN0micro+ disease are defined as isolated tumor cells (ITC) < 0.2 mm or micrometastasis 0.2 - 2 mm. Patients with pN0 disease are followed-up once every 6 months for 3 years and then annually for 2 years.

  • stage 2 (phase III randomized study): Patients undergo planned surgery and ex vivo SLNM as in stage 1. Patients with pN0micro- disease are assigned to arm C; patients with pN0micro+ disease are randomized to 1 of 2 intervention arms (arms A and B). .

    • Arm A (pN0micro+): Patients receive oral capecitabine twice daily on days 1-14 and oxaliplatin IV over 2 hours on day 1 OR oral capecitabine tw
      Sponsor: Jeroen Bosch Ziekenhuis

      Current Primary Outcome:

      • Accrual rate (total number of pN0 patients included in the registration study monthly/center) (stage 1)
      • Rate of upstaging in pN0 colon cancer patients (stage 1)
      • Disease-free survival (DFS) at 3 years (stage 2)
      • Percentage of successful sentinel lymph node mapping procedures using multivariate analysis (stage 2)


      Original Primary Outcome: Same as current

      Current Secondary Outcome:

      • Overall survival (OS) at 3 years (stage 2)
      • Stratified analysis of DFS and OS according to total harvested lymph nodes per resected specimen and chemotherapy regimen (capecitabine and oxaliplatin versus capecitabine alone) (stage 2)


      Original Secondary Outcome: Same as current

      Information By: National Cancer Institute (NCI)

      Dates:
      Date Received: March 31, 2010
      Date Started: July 2010
      Date Completion:
      Last Updated: August 9, 2013
      Last Verified: September 2011