MedTrace Logo

Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer

NCT06226857 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2024-01-29

No results posted yet for this study

Summary

Patients meeting the inclusion criteria will be randomized 1:1 into Cohort A (n ≈ 177) or Cohort BC (n ≈ 177). Cohort A is the control: patients receive combination chemotherapy with FOLFOX plus anti-EGFR therapy (panitumumab or cetuximab) based on RAS/BRAF wild-type data, according to clinical guidelines.

The BC cohort begins FOLFOX chemotherapy and simultaneously undergoes extensive molecular genetic profiling. Further, the BC cohort, depending on the profile, is divided into cohort B - patients without changes in alternative oncogenes, and cohort C - with changes in alternative oncogenes. The expected cohort ratio is 3:1 (\~120 and \~40 patients). Cohort B begins to receive anti-EGFR therapy in addition to chemotherapy, and the potentially resistant cohort C continues to receive chemotherapy alone or begins to receive bevacizumab if there are no contraindications.

Conditions

  • Colorectal Neoplasms
  • Chemotherapy Effect
  • Molecular Sequence Variation

Interventions

DRUG

Cetuximab

FOLFOX+cetuximab/panitumumab q2w until desease progression, deescalation to de Gramont+cetuximab/panitumumab is allowed after 8 cycles

Sponsors & Collaborators

  • Atlas Biomed

    collaborator INDUSTRY

  • N.N. Blokhin National Medical Research Center of Oncology

    collaborator OTHER

  • Moscow MultidisciplinaryClinical Center Kommunarka

    collaborator UNKNOWN

  • City Clinical Oncology Hospital No 1

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-17
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Russia

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226857 on ClinicalTrials.gov