This phase II trial is trying to determine whether it is better to give a targeted therapy (Panitumumab) alone or in combination with standard chemotherapy (5-FU) as a primary treatment for advanced colorectal cancer.
This trial is treating patients with RAS and BRAF-wild type colorectal cancer.
This is a systemic therapy trial.
You may be able to join this trial if:
- You have been diagnosed with cancer, but have not received any treatment.
- Your cancer has spread to other parts of the body.
You may be excluded from this trial if:
- You have a certain disease or psychological condition.
- You have been diagnosed with a prior or secondary type of cancer.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.
Clinical Summary Read More
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A randomised phase II study of Panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer
The primary endpoint for this trial is rate of progression free survival at 6 months, as defined by RECIST V1.1. Participants will be randomly assigned to one of two groups. In the intervention group, participants will receive targeted therapy (intravenous Panitumumab 6mg/Kg)alone, every two weeks, until disease progression or unacceptable toxicity. In the control group, participants will receive Panitumumab plus standard chemotherapy (5-fluorouracil / 5-FU) every two weeks until disease progression or toxicity. The chemotherapy schedule will consist of 5FU bolus 400mg/m2; leucovorin 200mg/m2; 5FU 46 hour infusion at 2400mg/m2.
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