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

NCT01097265 | Unknown Phase 2

• 4 other identifiers: JBZ-EnRoute+CDR0000668525EUDRACT-2010-018612-32EU-21016
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 11

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.

Conditions

Colorectal Cancer

Keywords

stage I colon cancer; stage II colon cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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)

Interventions

capecitabine DRUG

oxaliplatin DRUG

active surveillance OTHER

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

lymph node mapping PROCEDURE

sentinel lymph node biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Jeroen Bosch Ziekenhuis: lead

Study Sites (11)

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5211 NL, Netherlands

RECRUITING

Vrije Universiteit Medisch Centrum

Amsterdam, 1007 MB, Netherlands

RECRUITING

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 BE, Netherlands

RECRUITING

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

RECRUITING

Catharina Ziekenhuis

Eindhoven, 5602 ZA, Netherlands

RECRUITING

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

RECRUITING

Academisch Ziekenhuis Maastricht

Maastricht, 6202 AZ, Netherlands

RECRUITING

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

RECRUITING

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

RECRUITING

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

RECRUITING

Related Publications (1)

• Lips 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 RESULT

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Capecitabine; Oxaliplatin; Watchful Waiting; Chemotherapy, Adjuvant; Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Combined Modality Therapy; Therapeutics; Drug Therapy; Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Koop Bosscha, MD

  Jeroen Bosch Ziekenhuis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: July 1, 2010
• Primary Completion: January 1, 2015
• Last Updated: August 12, 2013

Record last verified: 2011-09

Locations

NL (11)