The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study
18 Years
N/A
Both
Colorectal Cancer
Trial Information
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.
- .
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Accrual rate (total number of pN0 patients included in the registration study monthly/center) (stage 1)
Safety Issue:
No
Principal Investigator
Koop Bosscha, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Jeroen Bosch Ziekenhuis
Authority:
Unspecified
Study ID:
CDR0000668525
NCT ID:
NCT01097265
Start Date:
July 2010
Completion Date:
Related Keywords:
- Colorectal Cancer
- stage I colon cancer
- stage II colon cancer
- Colonic Neoplasms
- Colorectal Neoplasms
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