The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS … (NCT05074966) | Clinical Trial Compass
UnknownPhase 3
The Efficacy and Safety of Modified XELOX(mXELOX) Plus Cetuximab vs FOLFOX Plus Cetuximab in RAS and BRAF WT mCRC Pts
China314 participantsStarted 2021-09-06
Plain-language summary
This is an open label, multicenter, randomized study in Chinese patients with RAS and BRAF wild-type mCRC. Participants were randomly assigned to cetuximab + FOLFOX (group A) and cetuximab + modified XELOX\[mXELOX\] (group B). All patients in groups A and B will be treated until progression of disease(PD), death, intolerable toxicity or withdrawal of informed consent, whichever occurs first.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Provide written informed consent (ICF) prior to any study procedure.
* Patient must be ≥18 years of age, at the time of signing the informed consent.
* Patients who had histologically or cytologically confirmed RAS and BRAF wild-type, initially unresectable metastatic adenocarcinoma of the left-sided colon or rectum, excluding appendiceal or anal cancer.
* The patients were willing to receive FOLFOX /mXELOX plus cetuximab as the first-line treatment choice after the diagnosis of mCRC;
* At least one measurable metastatic lesion(s) as defined by RECIST version 1.1. Eastern Cooperative Oncology Group (ECOG) performance score was 0-1 or KPS score ≥ 80.
* Life expectancy of at least 12 weeks in the opinion of the investigator.
* Neutrophils ≥ 1.5 × 109 / L, platelet ≥ 75 × 109 / L and hemoglobin ≥ 9 g / dl; Total bilirubin ≤ 1.5 × upper limit of normal value (ULN); ASAT (SGOT) and / or ALAT (SGPT) ≤ 2.5 × UNL (≤5×ULN in case of liver metastases）； Alkaline phosphatase ≤ 2.5 × UNL (≤ 5 × ULN in case of liver metastases; ≤ 10× ULN in case of bone metastasis ）； LDH \<1500 U/L; Creatinine clearance (calculated according to Cockcroft and Gault) \>60 mL/min or serum creatinine ≤1.5×ULN.
Exclusion Criteria:
* Previously received chemotherapy for CRC, except for adjuvant therapy\>9 months (chemotherapy with oxaliplatin) or \>6 months (chemotherapy without oxaliplatin) before the start of the study
* Patients that has been treated with monoclonal antibody, VEGF pat…
What they're measuring
1
median PFS
Timeframe: From Baseline to primary completion date, about 48 months