The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study
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 twice daily on days 1-14
alone according to standard protocol. Treatment repeats every 4 weeks for up to 8
courses. Patients are followed-up once every 6 months for 3 years and then
annually for 2 years.
- Arm B (pN0micro+): Patients are followed-up once every 6 months for 3 years and
then annually for 2 years.
- Arm C (pN0micro-): Patients are followed-up once every 6 months for 3 years and
then annually for 2 years.
- .
Interventional
Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Accrual rate (total number of pN0 patients included in the registration study monthly/center) (stage 1)
No
Koop Bosscha, MD
Principal Investigator
Jeroen Bosch Ziekenhuis
Unspecified
CDR0000668525
NCT01097265
July 2010
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