Clinical trial NCT01108107: Neoadjuvant Treatment of Colon Cancer
Official title: Neoadjuvant Chemotherapy and Biological Treatment for Patients With Locally Advanced Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colon Cancer
Keywords: Colon cancer
Neoadjuvant treatment
KRAS mutation
BRAF mutation
PIK3CA mutation
Possibly avoid chemotherapy after operation
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
First posted: 2010-04-21
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.
timeFrame: Within 1 week after surgery
Secondary outcomes:
measure: Recurrence free survival
timeFrame: Up to 2 years.
measure: Overall survival
timeFrame: Up to 2 years.
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev Hospital
city: Hilleroed
country: Denmark
facility: Dept. of Oncology, Hilleroed Hospital
city: Vejle
country: Denmark
facility: Department of Oncology, Vejle Hospital
Study officials:
affiliation: Vejle Hospital
name: Anders Jakobsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dam 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.