Individualised choise of 1.line chemotherapy of metastatic colo-rectal cancer. Can the blood test: TIMP-1 help the doctor to choose the best chemotherapy for the individual patient?

Individualised first line chemotherapy in metastatic colo-rectal cancer (mCRC). Is plasma TIMP-1 a predictive factor for best choise of first line chemotherapy in mCRC? - Individualised choise of 1.line chemotherapy in metastatic colo-rectal cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005495-42-DK

Enrollment

210

Registered

2012-04-18

Start date

2012-04-10

Completion date

Unknown

Last updated

2025-02-17

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

Conditions

Metastatic colon or rectal cancer MedDRA version: 14.1 Level: PT Classification code 10027457 Term: Metastases to liver System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: PT Classification code 10010035 Term: Colorectal cancer stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Xeloda Product Name: Xeloda Product Code: WC500058151 Pharmaceutical Form: Tablet Trade Name: Avastin Product Name: Avastin Product Code: WC500029271 Pharmaceutical Form: Infusion Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Histologically proven colon or rectal cancer Metastatic disease primary (stage IV) or due to relapse of previous (resected) stage I-III disease At least 1 measurable lesion 18 years of age or older WHO performance status 3 months Hgb>6.1 mmol/L, WBC>2.9, platelets>99 Kidney and liver function tests below certain defined upper limits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 90 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 120

Exclusion criteria

Exclusion criteria: Previous chemotherapy (including adjuvant after primary surgery) Previous cancer (except non melanoma skin cancer) Allergy to any of the therapeutical substances Neuropathy (e.g. alcoholic or diabetic) Recent myocardial infarction or stroke Uncontrollable hypertension

Design outcomes

Primary

Measure	Time frame
Main Objective: Aim is to investigate whether or not the cancer marker plasma TIMP-1 is related to probability of treatment response on chemotherapy with or without irinotecan;Secondary Objective: To investigate if addition of bevacizumab day 22 has specific impact on the initial effect of the chemotherapy as reflected in changes in plasma TIMP-1 and two other markers;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: CT scan every 9 weeks. Endpoint achieved at CT scan proving progression	—

Measure

Time frame

Main Objective: Aim is to investigate whether or not the cancer marker plasma TIMP-1 is related to probability of treatment response on chemotherapy with or without irinotecan;Secondary Objective: To investigate if addition of bevacizumab day 22 has specific impact on the initial effect of the chemotherapy as reflected in changes in plasma TIMP-1 and two other markers;Primary end point(s): Progression free survival (PFS);Timepoint(s) of evaluation of this end point: CT scan every 9 weeks. Endpoint achieved at CT scan proving progression

—

Secondary

Measure	Time frame
Secondary end point(s): Sequence of plasma TIMP-1 values days 0, 21, 42 and 63;Timepoint(s) of evaluation of this end point: Please se former cell	—

Countries

Denmark

Contacts

Public ContactClinical Research Unit 5072

Kell Osterlind

kell.oesterlind@rh.regionh.dk4535454985

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026