ActivePhase 2ACTRN12606000007538

Phase 1/2 study of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with liver metastases from colorectal carcinoma

A phase 1/2 study to test the safety and efficacy of a single implantation of SIR-Spheres plus systemic chemotherapy with FOLFOX4 in patients with liver metastases derived from colorectal carcinoma.


Sponsor

Sirtex Medical Limited

Enrollment

20 participants

Start Date

Jul 1, 2002

Study Type

Interventional

Conditions


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Phase 1/2 study of SIR-Spheres plus systemic chemotherapy with 5-fluorouracil, leucovorin and oxaliplatin in patients with liver metastases from colorectal carcinoma. You may be eligible if you are adults aged 18 and older with histologically confirmed adenocarcinoma of the colon or rectum. Participation typically involves medical assessments, possible treatment with the study intervention, and follow-up visits to track your health.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study is a multi-centre phase I/II dose-escalation study that aims to assess the safety and efficacy of a single implantation of SIR-Spheres when used in combination with systemic chemotherapy wit

The study is a multi-centre phase I/II dose-escalation study that aims to assess the safety and efficacy of a single implantation of SIR-Spheres when used in combination with systemic chemotherapy with FOLFOX4. Toxicity will be assessed after 3 cycles of treatment, at which stage the oxaliplatin will be escalated to full dose and the patients will go on receive a maximum of 12 cycles of chemotherapy. (The duration of the treatment cycles varies as it is based on the doctor's discretion. Ideally the treatment cycles would be 1 week of treatment and then 1 week of rest.)


Locations(1)

Australia

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ACTRN12606000007538