Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
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ClinicalTrials.gov Identifier: NCT01918527 |
Recruitment Status :
Recruiting
First Posted : August 7, 2013
Last Update Posted : September 28, 2020
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Colon Cancer | Drug: Capecitabine Drug: Oxaliplatin | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 250 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer |
Actual Study Start Date : | September 2013 |
Estimated Primary Completion Date : | February 2024 |
Estimated Study Completion Date : | February 2025 |
Arm | Intervention/treatment |
---|---|
A, Conventional treatment
Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
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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.
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Drug: Capecitabine
Orally on days 1-14: 2000 mg/m2/day q3w Drug: Oxaliplatin Intravenously on day 1: 130 mg/m2 q3w |
- Two-year disease free survival [ Time Frame: 2 years after completed study treatment ]
- Rate of patients fulfilling the criteria for adjuvant chemotherapy [ Time Frame: 6, 12, 18, and 24 months after completed study treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918527
Denmark | |
Aalborg University Hospital | Recruiting |
Aalborg, Denmark | |
Contact: Mette N Yilmaz, MD m.yilmaz@rn.dk | |
Principal Investigator: Mette N Yilmaz, MD | |
Rigshospitalet | Recruiting |
Copenhagen, Denmark | |
Contact: Lone Nørgaard, MD Lone.Noergaard.Petersen@regionh.dk | |
Principal Investigator: Lone Nørgaard, MD | |
Herlev Hospital | Recruiting |
Herlev, Denmark | |
Contact: Ole Larsen, MD ole.larsen@regionh.dk | |
Principal Investigator: Ole Larsen, MD | |
Hilleroed Hospital | Recruiting |
Hillerød, Denmark | |
Contact: Kell Østerlind, MD kell.oesterlind@regionh.dk | |
Principal Investigator: Keld Østerlind, MD | |
Roskilde Hospital | Recruiting |
Roskilde, Denmark | |
Contact: Jim S Larsen, MD JSLA@regionsjaelland.dk | |
Principal Investigator: Jim S Larsen, MD | |
Sygehus Sønderjylland | Recruiting |
Sønderborg, Denmark | |
Contact: Daniela Zitnjak, MD Daniela.Zitnjak@rsyd.dk | |
Principal Investigator: Daniela Zitnjak, 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 | Recruiting |
Bergen, Norway | |
Contact: Olav Dahl, MD olav.dahl@helse-bergen.no | |
Principal Investigator: Olav Dahl, MD | |
Sweden | |
Sahlgrenska University Hospital | Recruiting |
Göteborg, Sweden | |
Contact: Göran Carlssen, MD goran.u.carlsson@vgregion.se | |
Principal Investigator: Göran Carlsson, MD |
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 |
Responsible Party: | Vejle Hospital |
ClinicalTrials.gov Identifier: | NCT01918527 |
Other Study ID Numbers: |
NeoCol |
First Posted: | August 7, 2013 Key Record Dates |
Last Update Posted: | September 28, 2020 |
Last Verified: | September 2020 |
Locally advanced colon cancer Neoadjuvant chemotherapy |
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Colonic Diseases Intestinal Diseases Capecitabine Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |