Colon CancerPhase 3NCT01918527
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
A Phase 3 study testing Capecitabine and Oxaliplatin in people with Colon Cancer, run by Vejle Hospital at 9 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 9 sitesin 3 countries
- Study dates
- Sep 2013to Jun 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Denmark7 sites
Aalborg University Hospital
Aalborg
Rigshospitalet
Copenhagen
Herlev Hospital
Herlev
Hilleroed Hospital
Hillerød
Roskilde Hospital
Roskilde
Sygehus Sønderjylland
Sønderborg
Vejle Hospital
Vejle
About this study
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.
- Conditions
- Colon Cancer
- Being tested
- Capecitabine, Oxaliplatin
- Keywords
- Locally advanced colon cancer, Neoadjuvant chemotherapy
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Orally on days 1-14: 2000 mg/m2/day q3w
OxaliplatinDrug
Intravenously on day 1: 130 mg/m2 q3w
| Study group | Role | What they receive |
|---|---|---|
| A, Conventional treatment | Other | Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
| B, Neoadjuvant chemotherapy | Other | 3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated. Receives: Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-year disease free survival
Measured: 2 years after completed study treatment
Secondary outcomes (1)
Rate of patients fulfilling the criteria for adjuvant chemotherapy
Measured: 6, 12, 18, and 24 months after completed study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionJun 2023
- Study completionJun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vejle Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anders Jakobsen, DMSc, Study chair, Vejle Hospital, Vejle, DenmarkHenrik Jensen, MD, PhD, Principal investigator, Vejle Hospital, Vejle, DenmarkOlav Dahl, MD, Principal investigator, Haukeland University Hospital, Bergen, NorwayGöran Carlsson, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918527
- Sponsor's protocol ID
- NeoCol
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2013
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jensen LH, Kjaer M, Diness LV, Hollander NH, Rahr HB, Pfeffer F, Larsen FO, Lindebjerg J, Rafaelsen SR, Hansen TF, Timm S, Loes IM, Gogenur I, Zitnjak D, Andersen F, Petersen LN, Lindskog EB, Poulsen LO, Dahl O. Neoadjuvant Chemotherapy vs Upfront Surgery in Patients With Locally Advanced Colon Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 May 1;161(5):450-458. doi: 10.1001/jamasurg.2026.0085.
PubMed 41779406
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
- ClinicalTrials.gov ID
- NCT01918527
- Acronym / sponsor ID
- NeoCol
- Conditions
- Colon Cancer
- Keywords
- Locally advanced colon cancer, Neoadjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Vejle HospitalUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- Jun 2023 (actual)
- Study completion
- Jun 2026 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A, Conventional treatment | Other | Drug: Capecitabine, Drug: OxaliplatinOperation + 4 or 8 cycles of adjuvant chemotherapy, if indicated. |
| B, Neoadjuvant chemotherapy | Other | Drug: Capecitabine, Drug: Oxaliplatin3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CapecitabineOrally on days 1-14: 2000 mg/m2/day q3w | Drug | A, Conventional treatment, B, Neoadjuvant chemotherapy |
| OxaliplatinIntravenously on day 1: 130 mg/m2 q3w | Drug | A, Conventional treatment, B, Neoadjuvant chemotherapy |
Primary outcome
Two-year disease free survival
Time frame: 2 years after completed study treatment
1 secondary outcome
Rate of patients fulfilling the criteria for adjuvant chemotherapy
Time frame: 6, 12, 18, and 24 months after completed study treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Derived from this study: PubMed 41779406Jensen LH, Kjaer M, Diness LV, Hollander NH, Rahr HB, Pfeffer F, Larsen FO, Lindebjerg J, Rafaelsen SR, Hansen TF, Timm S, Loes IM, Gogenur I, Zitnjak D, Andersen F, Petersen LN, Lindskog EB, Poulsen LO, Dahl O. Neoadjuvant Chemotherapy vs Upfront Surgery in Patients With Locally Advanced Colon Cancer: A Randomized Clinical Trial. JAMA Surg. 2026 May 1;161(5):450-458. doi: 10.1001/jamasurg.2026.0085.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Jakobsen, DMSc study chair
Vejle Hospital, Vejle, Denmark
Henrik Jensen, MD, PhD principal investigator
Vejle Hospital, Vejle, Denmark
Olav Dahl, MD principal investigator
Haukeland University Hospital, Bergen, Norway
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Capecitabine and Oxaliplatin in people with Colon Cancer, run by Vejle Hospital at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Denmark, Norway, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-year disease free survival (time frame: 2 years after completed study treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.