Condition category
Cancer
Date applied
04/11/2010
Date assigned
20/12/2010
Last edited
20/12/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Martina Rebersek

ORCID ID

Contact details

Zaloska 2
Ljubljana
1000
Slovenia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

105/08/10

Study information

Scientific title

The influence of mutation status in KRAS and BRAF gene according to the classical histological parameters of tumor as a predictive factor of the aggressive course of disease in metastatic colorectal cancer: a single centre, prospective, cohort trial

Acronym

Study hypothesis

Knowledge of mutation status of KRAS and BRAF genes in addition to classical prognostic factors (histological characteristics of tumor and number of affected regional lymph nodes) improves the prediction of the aggressive course of disease in metastatic colorectal cancer to determine the start and the type of systemic therapy.

Ethics approval

The National Medical Ethics Committee, Ministry of Health, Republic of Slovenia, approved on the 26th August 2010 (ref: 105/08/10)

Study design

Single centre prospective cohort study

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Metastatic colorectal cancer

Intervention

Patients with metastatic colorectal adenocarcinoma will be treated with combination chemotherapy and targeted drugs in accordance with the guidelines for the systemic treatment of metastatic colorectal carcinoma and reviewed in accordance with good clinical practice and recommendations. The efficacy of treatment will be assessed in terms of RECIST criteria (version 1.1, Eur J Cancer 2009). During the treatment toxicity will be recorded according the Common Terminology Criteria for Adverse Events (CTCAE), version 4.02. In histological preparations, we will search for radical resection, the presence of vascular and perinevral invasion, lymphatic invasion, stage T, differentiation of tumor, number of affected regional lymph nodes. Molecular analysis for the presence of mutations in KRAS and BRAF gene we will do on the existing primary tumor or metastases, or in bioptic samples of primary tumor or metastases.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Progression-free survival (PFS)
2. Response rate (Response Evaluation Criteria in Solid Tumors [RECIST]) in correlation with histological parameters of tumor tissue, KRAS and BRAF status

Secondary outcome measures

Overall survival (OS)

Overall trial start date

29/11/2010

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Histologically confirmed colorectal cancer
3. Diagnosis of metastatic disease
4. Age 18 to 75 years
5. Eastern Cooperative Oncology Group (ECOG) performance score 0 - 2
6. Life expectancy of at least 3 months
7. Primary tumor with described histological features
8. Histology available for further analysis and molecular diagnostics
9. Determination of BRAF mutations in KRAS gene before starting treatment
10. Adequate haematological function (ANC greater than or equal to 1.5 x 10/9L, platelets greater than or equal to 100 x 10/9/L, Hb greater than or equal to 90 g/L)
11. Adequate liver function (serum bilirubin less than or equal to 1.5 x ULN, AST/ALP less than or equal to 2.5 x ULN
12. In case of liver metastases less than 5 x ULN), adequate renal function (calculated creatinine clearance greater than or equal to 50 mL/min)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400 patients

Participant exclusion criteria

1. ECOG performance score greater than 2
2. Participation in another clinical trial within 30 days prior to entering this study
3. Known hypersensitivity to any of the study drugs
4. Clinically significant cardiovascular disease (myocardial infarction less than or equal to 6 months before treatment start
5. Unstable angina
6. Uncontrolled hypertension
7. Arrhythmia requiring medication
8. Clinically significant renal disease (creatinine clearance less than 30 ml/min)
9. Liver cirrhosis Child B and C
10. Psychiatric disability to be clinically significant precluding informed consent
11. Evidence of any other disease
12. Metabolic dysfunction or laboratory findings, which give a suspicion of a disease or condition that contraindicates the use of any investigational drugs or means a higher risk for treatment-related complications

Recruitment start date

29/11/2010

Recruitment end date

31/12/2013

Locations

Countries of recruitment

Slovenia

Trial participating centre

Zaloska 2
Ljubljana
1000
Slovenia

Sponsor information

Organisation

Institute of Oncology Ljubljana (Slovenia)

Sponsor details

Zaloska 2
Ljubljana
1000
Slovenia
+38 (0)61 5879220
mrebersek@onko-i.si

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Institute of Oncology Ljubljana (Slovenia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes