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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mXELOX plus cetuximab | Experimental | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; |
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| FOLFOX plus cetuximab | Active Comparator | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab:500 mg/m2, IV, d1, q2w Oxaliplatin: 85 mg/m2, IV d1, q2w; Leucovorin: 400 mg/m2 IV d1, q2w; 5-FU: 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w; maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin: 400 mg/m2 IV d1, q2w; 5-FU: 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion, q2w (Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental: mXELOX plus cetuximab | Drug | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w; |
| Measure | Description | Time Frame |
|---|---|---|
| median PFS | from randomization to PD or death from any cause | From Baseline to primary completion date, about 48 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events(AEs) During Treatment Period | AEs included serious Adverse Events(SAEs) and non-serious AEs. Causality to study treatment was determined by the investigator. Severity was graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 | From Baseline to primary completion date, about 48 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aiping Zhou, Doctor | Contact | 8610-87788145 | ZHOUAP1825@126.COM | |
| Yongkun Sun, Doctor | Contact | 8610-87788145 | hsunyk@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Aiping Zhou, Doctor | Cancer Hospital & Institute, Chinese Academy of Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Hospital & Institute, Chinese Academy of Medical Sciences | Recruiting | Beijing | 100021 | China |
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patients with RAS/BRAF wild type left-sided mCRC will be randomized to two groups, which are mXELOX plus cetuximab and FOLFOX plus cetuximab.
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|
| Active Comparator: FOLFOX plus cetuximab | Drug | Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first) Oxaliplatin 85 mg/m2, IV d1; Leucovorin 400 mg/m2 IV d1; 5-FU 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion; q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin: 400 mg/m2 IV d1, q2w; 5-FU: 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48hours) IV continuous infusion, q2w (Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization) |
|
| Number of Participants With Hematology Abnormalities During Treatment Period | Hematology abnormalities include leukocyte count, hemoglobin, blood platelet count and neutrophil count | From Baseline to primary completion date, about 48 months |
| Number of Participants With Electrolyte Abnormalities During Treatment Period | Electrolyte abnormalities include K, Na, Ca and Mg | From Baseline to primary completion date, about 48 months |
| Number of Participants With Clinical chemistry Abnormalities During Treatment Period | Clinical chemistry abnormalities include blood urea nitrogen(BUN), serum creatinine, alkaline phosphatase(ALP), aspartate aminotransferase(AST), alanine aminotransferase(ALT), etc. | From Baseline to primary completion date, about 48 months |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-CR29 (EORTC QLQ-CR29) | Quality of life in patients with colorectal cancer is assessed using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) CR29. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. The maximum and minimum values are 104 and 25 respectively, and the smaller the value, the better the quality of life. | From Baseline to primary completion date, about 48 months |
| Change From Baseline in 5-level EuroQol-5 Dimensions(EQ-5D-5L) | Quality of life in patients with colorectal cancer is assessed using 5-level EuroQol-5 Dimensions(EQ-5D-5L). EQ-5D-5L comprises a short descriptive system questionnaire and a visual analogue scale (EQ VAS). The EQ-5D-5L descriptive system comprises five dimensions(MOBILITY, SELF-CARE, USUAL ACTIVITIES, PAIN /DISCOMFORT and ANXIETY / DEPRESSION) , each dimension now has five response levels: no problems, slight problems, moderate problems, severe problems, unable to /extreme problems. The EQ VAS records the respondent's overall current health on a vertical visual analogue scale, where the endpoints are labelled "The best health you can imagine" and "The worst health you can imagine". The EQ VAS provides a quantitative measure of the patient's perception of their overall health. One hundred means the best health you can imagine and Zero means the worst health you can imagine. It will be evaluated at Screening, Tumor Assessment Visit and End of Treatment visit. | From Baseline to primary completion date, about 48 months |
| objective response rate | The proportion of patients who acquired complete response and partial response during treatment. | From Baseline to primary completion date, about 48 months. |
| Overall Survival OS | from randomization to death from any cause | From Baseline to primary completion date, about 48 months |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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