Clinical trial · Interventional
Neoadjuvant Treatment of Colon Cancer
Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer
NCT01108107CI-TRIAL-00017989completedPhase 2ClinicalTrials.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)
This study will investigate * the effect of preoperative combination chemotherapy in patients with locally advanced colon cancer with mutation in the KRAS, BRAF or PIK3CA gene * the effect of preoperative combination chemotherapy in combination with biological treatment in patients without mutation in the KRAS, BRAF or PIK3CA gene.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Panitumumab | Biological | Panitumumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Chemotherapy only
- description
- Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- type
- OTHER
- label
- Chemotherapy + biological treatment
- description
- Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.
- interventionNames
- Drug: Oxaliplatin
- Drug: Capecitabine
- Biological: Panitumumab
Primary outcomes (1)
- measure
- The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically verified locally advanced T3 or T4 colon cancer assessed by CT scan * Analysis of KRAS, BRAF, PIK3CA * Age ≥18 år * Performance status ≤ 2 * Hematology * ANC ≥ 1.5x10\^9/l. Thrombocytes ≥ 100x10\^9/l. * Biochemistry * Bilirubinaemia ≤ 3 x UNL. ALAT ≤ 5 x UNL * Consent to translational research * Fertile women must present a negative pregnancy test and use secure birth control during and 3 months after treatment. * Written and orally informed consent. Exclusion Criteria: * Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) ≤ 1 year before enrollment, active severe infections or other concurrent disease. * Peripheral neuropathy NCI grade \>1 * Other malignant disease within 5 years prior to enrollment, except basal cell squamous carcinoma of the skin and cervical carcinoma-in-situ * Other investigational treatment within 30 days prior to treatment start * History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan. * Bleeding tumors * Hypersensitivity to one or more of the substances
References
Publications (1)
- DERIVEDDam C, Lund-Rasmussen V, Ploen J, Jakobsen A, Rafaelsen SR. Computed tomography assessment of early response to neoadjuvant therapy in colon cancer. Dan Med J. 2015 Jul;62(7):A5103. PMID 26183044