Clinical trial · Interventional
Neoadjuvant Chemotherapy Versus Standard Treatment in Patients With Locally Advanced Colon Cancer
NCT01918527CI-TRIAL-00123350completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- A, Conventional treatment
- description
- Operation + 4 or 8 cycles of adjuvant chemotherapy, if indicated.
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
- type
- OTHER
- label
- B, Neoadjuvant chemotherapy
- description
- 3 cycles of neoadjuvant chemotherapy + operation. Adjuvant chemotherapy only if indicated.
- interventionNames
- Drug: Capecitabine
- Drug: Oxaliplatin
Primary outcomes (1)
- measure
- Two-year disease free survival
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDJensen 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. PMID 41779406