The influence of micrometastases on prognosis and survival in stage I-II colon cancerpatients: the EnRoute+ study

Phase 3

Withdrawn

• Conditions: colon cancer; large intestine cancer; 10017990; 10017991

• Registration Number: NL-OMON36641
• Lead Sponsor: Jeroen Bosch Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 1000

Inclusion Criteria

- histological proven colon cancer, clinically localized, judged potentially resectable for cure, without intraoperatively gross nodal involvement
- radiological suspicion of colon cancer, clinically localized, judged potentially resectable for cure, without intraoperatively gross nodal involvement
- patients free of disseminated disease
- written informed consent

Exclusion Criteria

- previous chemotherapy
- high risk pN0 patient according to: less then 10 lymph nodes detected in resected specimen, or invasion in other organs (T4NxMx), or colon perforation at presentation, or obstruction at presentation, or angioinvasion at pathological examination.
- clinically positive nodal tumours or advanced disease (stage III / Dukes C)
- haematology (within 7 days before start of chemotherapy treatment): Hb <= 6,2 mmol/l, WBC <= 3,0 x 109/L, platelets <= 100 x 109/L
- renal function (within 7 days before start of chemotherapy treatment): creatinine < 1,25 UL or < 125 µmol/l; creat.clearance < 60 ml/min.(Cockcroft-Gault formula)
- liver function (within 7 days before start of treatment): bilirubin >= 1,5 UL, ASAT >= 2,5 UL, ALAT >= 2,5 UL, gamma-GT >= 2,5 UL, ALP >= 5 UL,
- other current serious illness or medical conditions: severe cardiac illness (NYHA class III-IV) , significant neurologic or psychiatric disorders, uncontrolled infections, active DIC, other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- known hypersensitivity to study drugs
- definite contraindications for the use of corticosteroids
- use of immunosuppressive or antiviral drugs
- any other experimental drugs within a 4-week period prior to start of surgery and adjuvant chemotherapy and throughout the study period
- pregnancy or lactation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is 3-year DFS in study groups (proportion of patients without<br /><br>local or distant recurrence, or second primary colorectal cancer, during the<br /><br>defined period of time). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints are rate of upstaging in pN0 colonic cancer patients<br /><br>(total number pN0micro+ patients x 100 / total number pN0 colon cancer<br /><br>patients) and 3-year overall survival.</p><br>