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

Recruiting Phase 3 Interventional Study
Colorectal Neoplasms Chemotherapy Effect Molecular Sequence Variation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
355 (estimated)
Sponsor
City Clinical Oncology Hospital No 1 · Government
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About This Trial
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 g…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Informed consent signed before commencing any procedures related to the clinical trial. 2. Age ≥18 years. 3. ECOG status 0-2. 4. Life expectancy greater than 12 weeks as assessed by the investigator. 5. Verified diagnosis of colorectal adenocarcinoma (C18.5, C19, C20). 6. Met…
Contacts

Ilya Pokataev, phD

+74955369406

pokia@mail.ru

CONTACT

Maria Byakhova, phD

+79151751299

biakhovamm@mail.ru

CONTACT