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

Phase 2

• Conditions: Colorectal Cancer

• Registration Number: NCT01097265
• Lead Sponsor: Jeroen Bosch Ziekenhuis

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 Description

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.

* .

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Study First Posted: 2010-04-01
• Study Start: 2010-07
• Status Verified: 2011-09
• Last Update Submitted: 2013-08-09
• Last Update Posted: 2013-08-12
• Primary Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (11)

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Netherlands

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital; 🇳🇱 Amsterdam, Netherlands

Jeroen Bosch Ziekenhuis; 🇳🇱 's-Hertogenbosch, Netherlands

Vrije Universiteit Medisch Centrum; 🇳🇱 Amsterdam, Netherlands

Academisch Medisch Centrum at University of Amsterdam; 🇳🇱 Amsterdam, Netherlands

Leiden University Medical Center; 🇳🇱 Leiden, Netherlands

University Medical Center Rotterdam at Erasmus Medical Center; 🇳🇱 Rotterdam, Netherlands

Universitair Medisch Centrum St. Radboud - Nijmegen; 🇳🇱 Nijmegen, Netherlands

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands

Academisch Ziekenhuis Maastricht; 🇳🇱 Maastricht, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands