Neoadjuvant Treatment of Colon Cancer

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108107
• Other study ID #: S-20100014
• Status: Completed
• Phase: Phase 2
• First received: April 14, 2010
• Last updated: May 20, 2015
• Start date: April 2010
• Est. completion date: March 2015

Study information

• Verified date: March 2014
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: March 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Drug:
• Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
• Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
• Oxaliplatin
130 mg/m2 intravenously on day 1 of a 3-weekly cycle
• Capecitabine
2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle

Biological:
• Panitumumab
9 mg/kg intravenously on day 1 of a 3-weekly cycle

Locations

Country	Name	City	State
Denmark	Department of Oncology, Herlev Hospital	Herlev
Denmark	Dept. of Oncology, Hilleroed Hospital	Hilleroed
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.		Within 1 week after surgery	No
Secondary	Recurrence free survival		Up to 2 years.	No
Secondary	Overall survival		Up to 2 years.	No