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Neoadjuvant Treatment of Colon Cancer

Primary Purpose

Colon Cancer

Status

Completed

Phase

Phase 2

Locations

Denmark

Study Type

Interventional

Intervention

Oxaliplatin

Capecitabine

Oxaliplatin

Capecitabine

Panitumumab

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring Colon cancer, Neoadjuvant treatment, KRAS mutation, BRAF mutation, PIK3CA mutation, Possibly avoid chemotherapy after operation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Department of Oncology, Herlev Hospital
Dept. of Oncology, Hilleroed Hospital
Department of Oncology, Vejle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Chemotherapy only

Chemotherapy + biological treatment

Arm Description

Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene

Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.

Outcomes

Primary Outcome Measures

The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.

Secondary Outcome Measures

Recurrence free survival

Overall survival

Full Information

NCT ID

NCT01108107

First Posted

April 14, 2010

Last Updated

May 20, 2015

Sponsor

Vejle Hospital

Collaborators

Herlev Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01108107

Brief Title

Neoadjuvant Treatment of Colon Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2014

Overall Recruitment Status

Completed

Study Start Date

April 2010 (undefined)

Primary Completion Date

September 2013 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Vejle Hospital

Collaborators

Herlev Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

76 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Chemotherapy only

Arm Type

Other

Arm Description

Chemotherapy only, if mutations in KRAS, BRAF or PIK3CA gene

Arm Title

Chemotherapy + biological treatment

Arm Type

Other

Arm Description

Addition of biological treatment, if no mutations in KRAS, BRAF, and PIK3CA genes.

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Capecitabine

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Panitumumab

Intervention Description

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

Primary Outcome Measure Information:

Title

The frequency of patients requiring adjuvant chemotherapy based on the histological evaluation of the preparation from the operation.

Time Frame

Within 1 week after surgery

Secondary Outcome Measure Information:

Title

Recurrence free survival

Time Frame

Up to 2 years.

Title

Overall survival

Time Frame

Up to 2 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Jakobsen, DMSc

Organizational Affiliation

Vejle Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Oncology, Herlev Hospital

City

Herlev

ZIP/Postal Code

DK-2730

Country

Denmark

Facility Name

Dept. of Oncology, Hilleroed Hospital

City

Hilleroed

ZIP/Postal Code

3400

Country

Denmark

Facility Name

Department of Oncology, Vejle Hospital

City

Vejle

ZIP/Postal Code

DK-7100

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

26183044

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.

Results Reference

derived

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Neoadjuvant Treatment of Colon Cancer

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