Randomized study of the detection of mutations by BEAMing technology in advance of the radiological diagnosis of progression in patients with metastatic colorectal cancer and primary tumor in the left colon / rectum

Randomized study of the detection of RAS / BRAF mutations by BEAMing technology in advance of the radiological diagnosis of progression in patients with metastatic colorectal cancer RAS / BRAF WT and primary tumor in the left colon / rectum

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004231-72-ES

Enrollment

Registered

2019-06-28

Start date

2019-06-27

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Median of the progression-free survival of patients with mCRC who maintains the treatment in conventional 1st line, QT + anti-EFGR, versus patients who withdraw anti-EGFR therapy after detection of mutations of the RAS gene / BRAF through the OncoBEAM ™ test. MedDRA version: 20.0 Level: PT Classification code 10061451 Term: Colorectal cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified

Interventions

Trade Name: 5-Fluorouracilo Pharmaceutical Form: INN or Proposed INN: 5-fluorouracilo CAS Number: 51-21-8 Current Sponsor code: Accord H

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patients older than or equal to 18 years old. ? Informed consent. ? Karnofsky index =70% at the time of inclusion of the trial. ? Patients with unresectable CCRm. ? Location of the primary tumor in the left colon or rectum. ? Genotype RAS / BRAF WT by OncoBEAM ™ before starting the 1st line treatment. ? There is no contraindication or QT in Oxaliplatin / Irinotecan and anti-EGFR 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 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? History of a primary cancer other than CRC in the last five years (with the exception of non-melanoma skin cancer and carcinoma in situ of the cervix). ? Any type of previous treatment for your metastatic disease. ? Patients with resectable disease and / or who receive surgical treatment of the tumors. ? Analytical alterations that avoid inclusion in Clinical Trial o Hemoglobin <9 g / dL o Platelets <100x109 / L or Neutrophils <1.5x109L o Total bilirubin ?1.5 x ULN or ALAT and ASAT ?2.5 x ULN (?5x ULN in case of liver metastases) o Creatinine ?1.5 x ULN or Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: Median of the progression-free survival of patients with mCRC who maintains the treatment in conventional 1st line, QT + anti-EFGR, versus patients who withdraw anti-EGFR therapy after detection of mutations of the RAS gene / BRAF through the OncoBEAM test.; Secondary Objective: ? Evaluate the progression-free survival rate at 12 months from the start of the 1st line of treatment, performing the Kaplan-Mayer analysis. ? Cost analysis of the implementation of the OncoBEAM test and variations in the treatment of 1st line, in addition to the current diagnosis disease progression (TAC) diagnosis technique, for the control and follow-up of patients with CCRm. ;Primary end point(s): Median of the progression-free survival of patients with mCRC who maintains the treatment in conventional 1st line, QT + anti-EFGR, versus patients who withdraw anti-EGFR therapy after detection of mutations of the RAS gene / BRAF through the OncoBEAM test.;Timepoint(s) of evaluation of this end point: Every two weeks	—

Measure

Time frame

Main Objective: Median of the progression-free survival of patients with mCRC who maintains the treatment in conventional 1st line, QT + anti-EFGR, versus patients who withdraw anti-EGFR therapy after detection of mutations of the RAS gene / BRAF through the OncoBEAM test.; Secondary Objective: ? Evaluate the progression-free survival rate at 12 months from the start of the 1st line of treatment, performing the Kaplan-Mayer analysis. ? Cost analysis of the implementation of the OncoBEAM test and variations in the treatment of 1st line, in addition to the current diagnosis disease progression (TAC) diagnosis technique, for the control and follow-up of patients with CCRm. ;Primary end point(s): Median of the progression-free survival of patients with mCRC who maintains the treatment in conventional 1st line, QT + anti-EFGR, versus patients who withdraw anti-EGFR therapy after detection of mutations of the RAS gene / BRAF through the OncoBEAM test.;Timepoint(s) of evaluation of this end point: Every two weeks

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Secondary

Measure	Time frame
Secondary end point(s): ? Evaluate the progression-free survival rate at 12 months from the start of the 1st line of treatment, performing the Kaplan-Mayer analysis. ? Cost analysis of the implementation of the OncoBEAM test and variations in the treatment of 1st line, in addition to the current diagnosis disease progression (TAC) diagnosis technique, for the control and follow-up of patients with CCRm. ;Timepoint(s) of evaluation of this end point: Every two weeks	—

Measure

Time frame

Secondary end point(s): ? Evaluate the progression-free survival rate at 12 months from the start of the 1st line of treatment, performing the Kaplan-Mayer analysis. ? Cost analysis of the implementation of the OncoBEAM test and variations in the treatment of 1st line, in addition to the current diagnosis disease progression (TAC) diagnosis technique, for the control and follow-up of patients with CCRm. ;Timepoint(s) of evaluation of this end point: Every two weeks

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Countries

Spain

Contacts

Public ContactClinical Studies Platform

FIMABIS

gloria.luque@ibima.eu34951 291 977

Outcome results

None listed

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