Actively Recruiting
Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
Led by City Clinical Oncology Hospital No 1 · Updated on 2024-01-29
355
Participants Needed
3
Research Sites
206 weeks
Total Duration
On this page
Sponsors
C
City Clinical Oncology Hospital No 1
Lead Sponsor
A
Atlas Biomed
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before starting any trial procedures
- Age 18 years or older
- ECOG performance status between 0 and 2
- Life expectancy longer than 12 weeks
- Diagnosed with colorectal adenocarcinoma (C18.5, C19, C20)
- Metastatic unresectable disease with no prior systemic therapy for metastatic cancer
- Primary tumor located on the left side of the colon (from splenic flexure onward)
- Confirmed wild-type KRAS and NRAS from tumor tissue
- Adequate blood counts and organ function including neutrophils ≥1.5×10^9/L, platelets ≥100×10^9/L, hemoglobin ≥90 g/L, creatinine clearance >50 ml/min, bilirubin <1.5 times normal, ALT or AST within specified limits
- Sufficient tumor material available for molecular genetic testing collected within 24 months before study entry
You will not qualify if you...
- Previous systemic therapy for metastatic disease
- Presence of KRAS, NRAS, or V600E mutations (except unknown BRAF status)
- Uncertain KRAS/NRAS mutation status
- Other active malignancies except certain treated skin or cervical cancers within 5 years
- Pregnant or breastfeeding women or those planning pregnancy during treatment and 6 months after
- HIV infection or active hepatitis B or C
- Complicated primary tumor requiring urgent surgery (unless resolved)
- Any disease or condition that prevents participation as judged by the investigator
- Inability to establish central venous access
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Moscow Multidiciplinary Clinical Center Kommunarka
Moscow, Russia, 108814
Actively Recruiting
2
N.N Blokhin Cancer Reserch Center
Moscow, Russia, 115478
Actively Recruiting
3
Reutov Clinical hospital
Reutov, Russia, 143964
Actively Recruiting
Research Team
I
Ilya Pokataev, phD
CONTACT
M
Maria Byakhova, phD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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