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Tests treatment safety and results for Colorectal Neoplasms
Official title Other Oncogene Mutations for Anti-EGFR Efficacy in Patients With Left-sided RAS-wild Type Metastatic Colorectal Cancer
ClinicalTrials.gov ID: NCT06226857
What this study is testing
What is Cetuximab?
Cetuximab is an investigational medicine, being studied as a potential treatment for colorectal neoplasms.
Also referred to as panitumumab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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).
You likely can't join if
- Previous systemic therapy for metastatic disease.
- Presence of KRAS/NRAS/V600E mutations (except for unknown BRAF status).
- Uncertain KRAS/NRAS status
- The presence of any other malignant tumor, with the exception of radically treated basal cell carcinoma, cervical cancer in situ, currently or within...
- HIV infection, active hepatitis B, active hepatitis C.
- Complicated primary tumor, requiring urgent surgical intervention. After it is eliminated, the patient can participate in the study.
See the full eligibility criteria
- 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...
- 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.
- Previous systemic therapy for metastatic disease.
- Presence of KRAS/NRAS/V600E mutations (except for unknown BRAF status).
- Uncertain KRAS/NRAS status
- 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...
- HIV infection, active hepatitis B, active hepatitis C.
- Complicated primary tumor, requiring urgent surgical intervention. After it is eliminated, the patient can participate in the study.
- The presence of a disease or condition that, in the opinion of the investigator, prevents the patient from participating in the study.
- Impossibility of organizing central venous access.
The study team makes the final eligibility decision.
Where it's taking place
- Moscow, Russia
- Reutov, Russia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moscow, Russia; Reutov, Russia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.