Study of Micrometastases in Patients With Stage I or Stage II Localized Colon Cancer That Can Be Removed by Surgery
This study is currently recruiting participants.
Verified September 2011 by National Cancer Institute (NCI)
Sponsor:
Jeroen Bosch Ziekenhuis
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01097265
First received: March 31, 2010
Last updated: September 20, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: capecitabine Drug: oxaliplatin Other: active surveillance Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: lymph node mapping Procedure: sentinel lymph node biopsy |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | The Influence of Micrometastases on Prognosis and Survival in Stage I-II Colon Cancer Patients: The EnRoute+ Study |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Accrual rate (total number of pN0 patients included in the registration study monthly/center) (stage 1) [ Designated as safety issue: No ]
- Rate of upstaging in pN0 colon cancer patients (stage 1) [ Designated as safety issue: No ]
- Disease-free survival (DFS) at 3 years (stage 2) [ Designated as safety issue: No ]
- Percentage of successful sentinel lymph node mapping procedures using multivariate analysis (stage 2) [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall survival (OS) at 3 years (stage 2) [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
| Estimated Enrollment: | 1500 |
| Study Start Date: | July 2010 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
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.
- .
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01097265
Locations
| Netherlands | |
| Jeroen Bosch Ziekenhuis | Recruiting |
| 's-Hertogenbosch, Netherlands, 5211 NL | |
| Contact: Contact Person 31-73-699-2701 k.bosscha@jbz.nl | |
| Academisch Medisch Centrum at University of Amsterdam | Recruiting |
| Amsterdam, Netherlands, 1105 AZ | |
| Contact: Contact Person 31-20-566-9111 | |
| Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital | Recruiting |
| Amsterdam, Netherlands, 1066 BE | |
| Contact: Contact Person 31-20-512-9111 | |
| Vrije Universiteit Medisch Centrum | Recruiting |
| Amsterdam, Netherlands, 1007 MB | |
| Contact: Contact Person 31-20-444-4300 | |
| Catharina Ziekenhuis | Recruiting |
| Eindhoven, Netherlands, 5602 ZA | |
| Contact: Contact Person 31-40-239-9111 | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands, 9700 RB | |
| Contact: Contact Person 31-50-361-2317 | |
| Leiden University Medical Center | Recruiting |
| Leiden, Netherlands, 2300 RC | |
| Contact: Contact Person 31-71-526-2309 c.j.h.van_de_velde@lumc.nl | |
| Academisch Ziekenhuis Maastricht | Recruiting |
| Maastricht, Netherlands, 6202 AZ | |
| Contact: Contact Person 31-43-387-7025 | |
| Universitair Medisch Centrum St. Radboud - Nijmegen | Recruiting |
| Nijmegen, Netherlands, NL-6500 HB | |
| Contact: Contact Person 31-24-361-0353 c.punt@onco.umcn.nl | |
| University Medical Center Rotterdam at Erasmus Medical Center | Recruiting |
| Rotterdam, Netherlands, 3000 CA | |
| Contact: Contact Person 31-10-463-5995 w.r.schouten@erasmusmc.nl | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584 CX | |
| Contact: Contact Person 31-30-250-9111 | |
Sponsors and Collaborators
Jeroen Bosch Ziekenhuis
Investigators
| Principal Investigator: | Koop Bosscha, MD | Jeroen Bosch Ziekenhuis |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT01097265 History of Changes |
| Other Study ID Numbers: | CDR0000668525, JBZ-EnRoute+, EUDRACT-2010-018612-32, EU-21016 |
| Study First Received: | March 31, 2010 |
| Last Updated: | September 20, 2011 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
stage I colon cancer stage II colon cancer |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Oxaliplatin Capecitabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013