Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vejle Hospital
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01918527
First received: August 6, 2013
Last updated: May 28, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.

Patients receiving neoadjuvant chemotherapy may not need adjuvant chemotherapy after the operation and, if this is the case, they will be spared of 5 cycles of chemotherapy.


Condition Intervention Phase
Colon Cancer
Drug: Capecitabine
Drug: Oxaliplatin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Two-year disease free survival [ Time Frame: 2 years after completed study treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of patients fulfilling the criteria for adjuvant chemotherapy [ Time Frame: 6, 12, 18, and 24 months after completed study treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 250
Study Start Date: September 2013
Estimated Study Completion Date: August 2019
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A, Conventional treatment
Operation + 8 cycles of adjuvant chemotherapy, if indicated.
Drug: Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
Drug: Oxaliplatin
Intravenously on day 1: 130 mg/m2 q3w
B, Neoadjuvant chemotherapy
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
Drug: Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w
Drug: Oxaliplatin
Intravenously on day 1: 130 mg/m2 q3w

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically verified locally advanced T3 (ETI > 5 mm) or T4 colon cancer assessed by CT scan.
  • Age ≥ 18 years
  • PS 0-2.
  • Hematology ANC ≥1.5x10^9/l. Thrombocytes ≥ 100x10^9/l.
  • Biochemistry Bilirubinemia ≤ 3 x upper normal level. ALAT ≤ 5 x upper normal value
  • Consent to translational research
  • Fertile women must present a negative pregnancy test and use secure contraceptives during and 3 months after treatment.
  • Written and orally informed consent.

Exclusion Criteria:

  • Patients with distant metastases.
  • Acute operation
  • Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before inclusion.
  • Active, serious infection or other serious disease.
  • Peripheral neuropathy NCI grade > 1
  • Other malignant disease within 5 years prior to study enrollment, except basocellular or squamous skin cancer and carcinoma in situ cervicis uteri.
  • Other investigational treatment within 30 days prior to treatment start.
  • Hypersensitivity to one or more of the active or auxiliary substances.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918527

Locations
Denmark
Bispebjerg Hospital Not yet recruiting
Copenhagen, Denmark
Rigshospitalet Not yet recruiting
Copenhagen, Denmark
Contact: Kell Oesterlind, MD       kell.oesterlind@regionh.dk   
Principal Investigator: Kell Oesterlinn, MD         
Hvidovre Hospital Not yet recruiting
Copenhagen, Denmark
Herlev Hospital Recruiting
Herlev, Denmark
Contact: Ole Larsen, MD       ole.larsen@regionh.dk   
Principal Investigator: Ole Larsen, MD         
Hilleroed Hospital Not yet recruiting
Hillerød, Denmark
Contact: Fahimeh Andersen, MD       fahimeh.andersen@regionh.dk   
Principal Investigator: Fahimeh Andersen, MD         
Roskilde Hospital Recruiting
Roskilde, Denmark
Contact: Jim S Larsen, MD       JSLA@regionsjaelland.dk   
Principal Investigator: Jim S Larsen, MD         
Vejle Hospital Recruiting
Vejle, Denmark
Contact: Anders Jakobsen, DMSc       anders.jakobsen@rsyd.dk   
Contact: Henrik Jensen, MD, PhD       lars.henrik.jensen@rsyd.dk   
Principal Investigator: Henrik Jensen, MD, PhD         
Sub-Investigator: John Ploen, MD         
Norway
Haukeland University Hospital Not yet recruiting
Bergen, Norway
Contact: Olav Dahl, MD       olav.dahl@helse-bergen.no   
Principal Investigator: Olav Dahl, Professor, MD         
Oslo University Hospital Not yet recruiting
Oslo, Norway
Contact: Morgen Braendengen, MD       UXBRNM@ous-hf.no   
Principal Investigator: Morten Braendengen, MD         
Sweden
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Sweden
Contact: Göran Carlssen, MD       goran.u.carlsson@vgregion.se   
Principal Investigator: Göran Carlsson, MD         
Sponsors and Collaborators
Vejle Hospital
Investigators
Study Chair: Anders Jakobsen, DMSc Vejle Hospital, Vejle, Denmark
Principal Investigator: Henrik Jensen, MD, PhD Vejle Hospital, Vejle, Denmark
Principal Investigator: Olav Dahl, MD Haukeland University Hospital, Bergen, Norway
Principal Investigator: Göran Carlsson, MD Sahlgrenska University Hospital, Gothenburg, Sweden
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01918527     History of Changes
Other Study ID Numbers: NeoCol
Study First Received: August 6, 2013
Last Updated: May 28, 2014
Health Authority: Denmark: National Board of Health

Keywords provided by Vejle Hospital:
Locally advanced colon cancer
Neoadjuvant chemotherapy

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Diseases
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Capecitabine
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014