Neoadjuvant Treatment of Colon Cancer

Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01108107

Enrollment

Registered

2010-04-21

Start date

2010-04-30

Completion date

2015-03-31

Last updated

2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer

Keywords

Colon cancer, Neoadjuvant treatment, KRAS mutation, BRAF mutation, PIK3CA mutation, Possibly avoid chemotherapy after operation

Brief summary

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.

Interventions

DRUGOxaliplatin

130 mg/m2 intravenously on day 1 of a 3-weekly cycle

DRUGCapecitabine

2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle

BIOLOGICALPanitumumab

9 mg/kg intravenously on day 1 of a 3-weekly cycle

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.	Within 1 week after surgery

Secondary

Measure	Time frame
Recurrence free survival	Up to 2 years.
Overall survival	Up to 2 years.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026