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

Primary Purpose

Colon Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Capecitabine
Oxaliplatin
Sponsored by
Vejle Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Locally advanced colon cancer, Neoadjuvant chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Aalborg University Hospital
  • Rigshospitalet
  • Herlev Hospital
  • Hilleroed Hospital
  • Roskilde Hospital
  • Sygehus Sønderjylland
  • Vejle Hospital
  • Haukeland University Hospital
  • Sahlgrenska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

A, Conventional treatment

B, Neoadjuvant chemotherapy

Arm Description

Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.

3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.

Outcomes

Primary Outcome Measures

Two-year disease free survival

Secondary Outcome Measures

Rate of patients fulfilling the criteria for adjuvant chemotherapy

Full Information

First Posted
August 6, 2013
Last Updated
October 5, 2023
Sponsor
Vejle Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01918527
Brief Title
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Official Title
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 2013 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vejle Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
Locally advanced colon cancer, Neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A, Conventional treatment
Arm Type
Other
Arm Description
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
Arm Title
B, Neoadjuvant chemotherapy
Arm Type
Other
Arm Description
3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Intervention Description
Orally on days 1-14: 2000 mg/m2/day q3w
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Intravenously on day 1: 130 mg/m2 q3w
Primary Outcome Measure Information:
Title
Two-year disease free survival
Time Frame
2 years after completed study treatment
Secondary Outcome Measure Information:
Title
Rate of patients fulfilling the criteria for adjuvant chemotherapy
Time Frame
6, 12, 18, and 24 months after completed study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jakobsen, DMSc
Organizational Affiliation
Vejle Hospital, Vejle, Denmark
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Henrik Jensen, MD, PhD
Organizational Affiliation
Vejle Hospital, Vejle, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olav Dahl, MD
Organizational Affiliation
Haukeland University Hospital, Bergen, Norway
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Göran Carlsson, MD
Organizational Affiliation
Sahlgrenska University Hospital, Gothenburg, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University Hospital
City
Aalborg
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
Country
Denmark
Facility Name
Hilleroed Hospital
City
Hillerød
Country
Denmark
Facility Name
Roskilde Hospital
City
Roskilde
Country
Denmark
Facility Name
Sygehus Sønderjylland
City
Sønderborg
Country
Denmark
Facility Name
Vejle Hospital
City
Vejle
Country
Denmark
Facility Name
Haukeland University Hospital
City
Bergen
Country
Norway
Facility Name
Sahlgrenska University Hospital
City
Göteborg
Country
Sweden

12. IPD Sharing Statement

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

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