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

Phase 1

• 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 (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2018-004231-72-ES
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 80

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

? 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified