Testing Gene Changes to Guide Treatment in Bowel Cancer
Tests whether added gene changes predict response to cetuximab in colorectal cancer.
Plain-language title generated from the registry record
Registry title: Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
Key facts
- Where
- Moscow and Reutov, RussiaSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 99 years old?
Source: NCT06226857, who can take part
Where in Russia
- Moscow Multidiciplinary Clinical Center KommunarkaMoscow, RussiaTaking people
- N.N Blokhin Cancer Reserch CenterMoscow, RussiaTaking people
- Reutov Clinical hospitalReutov, RussiaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- City Clinical Oncology Hospital No 1
- Trial code
- NCT06226857
- Record updated
- 29 January 2024
- Original description
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.Read full original descriptionShow less
Predictive Value of Other Oncogene Mutations for Anti-EGFR Monoclonal Antibodies Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer: Multicenter Randomized Phase III 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 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.
Inclusion: Informed consent signed before commencing any procedures related to the clinical trial; Age ≥18 years; ECOG status 0-2; Life expectancy greater than 12 weeks as assessed by the investigator; Verified diagnosis of colorectal adenocarcinoma (C18.5, C19, C20); Metastatic unresectable form of the disease that has not previously received any systemic therapy for the metastatic process (previous neo-/adjuvant therapy completed at least 6 months before the detection of metastases is allowed); Left-sided localization of the primary tumor (from the splenic flexure of the colon inclusive); Verified wild type KRAS, NRAS determined from tumor tissue; Satisfactory function of hematopoiesis and internal organs:; absolute number of neutrophils ≥ 1.5×10 9 /l; platelets ≥ 100×10 9 /l; hemoglobin ≥ 90 g/l; creatinine clearance above 50 ml/min; total bilirubin <1.5 X the upper limit of normal; ALT or AST >5 X the upper limit of normal in the presence of liver metastases or >2.5 X the upper limit of normal in the absence of liver metastases; Availability of a sufficient amount of tumor material for molecular genetic research. Tumor material must be collected no more than 24 months before inclusion in the study.
Exclusion: Previous systemic therapy for metastatic disease; Complicated primary tumor, requiring urgent surgical intervention. After it is eliminated, the patient can participate in the study; The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within 5 years before inclusion in the study. Pregnant and lactating women, as well as planning pregnancy during the period of therapy in a clinical trial and 6 months after the end of therapy; HIV infection, active hepatitis B, active hepatitis C; The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study; Presence of KRAS/NRAS/V600E mutations (except for unknown BRAF status); Uncertain KRAS/NRAS status; Impossibility of organizing central venous access.