Clinical trial · Interventional
Study of Micrometastases in Patients With Stage I or Stage II Localized Colon Cancer That Can Be Removed by Surgery
The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study
NCT01097265CI-TRIAL-00011710unknownPhase 2 / Phase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| active surveillance | Other | — | UNRESOLVED |
| adjuvant therapy | Procedure | — | UNRESOLVED |
| capecitabine | Drug | Capecitabine | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lymph node mapping | Procedure | — | UNRESOLVED |
| oxaliplatin | Drug | Oxaliplatin | ALIAS |
| sentinel lymph node biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Accrual rate (total number of pN0 patients included in the registration study monthly/center) (stage 1)
- measure
- Rate of upstaging in pN0 colon cancer patients (stage 1)
- measure
- Disease-free survival (DFS) at 3 years (stage 2)
- measure
- Percentage of successful sentinel lymph node mapping procedures using multivariate analysis (stage 2)
Secondary outcomes (2)
- measure
- Overall survival (OS) at 3 years (stage 2)
- measure
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 drugsReferences
Publications (1)
- RESULTLips DJ, Koebrugge B, Liefers GJ, van de Linden JC, Smit VT, Pruijt HF, Putter H, van de Velde CJ, Bosscha K. The influence of micrometastases on prognosis and survival in stage I-II colon cancer patients: the Enroute plus sign in circle Study. BMC Surg. 2011 May 11;11:11. doi: 10.1186/1471-2482-11-11. PMID 21569373