Study on Adding Total Ablative Therapy to Standard Treatment for Limited Metastatic Colorectal Cancer (ERASur Study)

Sponsor: Alliance for Clinical Trials in Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05673148

Provider View

This clinical trial is exploring whether adding a focused treatment called total ablative therapy to the usual drug treatment can help control colorectal cancer that has spread to up to four areas in the body.

Patient Parameters

Program Overview

This study is testing if adding a treatment called total ablative therapy to the usual drug treatment can help control colorectal cancer that has spread to a few areas in the body. Normally, patients receive drugs through a vein or by mouth to stop the cancer from growing or spreading. Total ablative therapy aims to destroy cancer at specific sites using focused radiation, surgery, or heat. These methods have been tested for safety, but it's not yet proven if they are beneficial for this stage of cancer. The study will see if this approach can shrink or remove tumors or prevent them from coming back.

Description

The main goal of this study is to see if adding total ablative therapy to standard drug treatment can help patients with newly diagnosed limited metastatic colorectal cancer live longer. The study will also look at how long patients stay free from cancer events, the side effects of the treatments, and how long it takes for cancer to return after treatment.

Participants will be randomly assigned to one of two groups:

  • Group 1: Will receive total ablative therapy, which includes focused radiation, surgery, or heat treatment, along with standard chemotherapy. They will also have regular scans to monitor their progress.
  • Group 2: Will receive standard chemotherapy and regular scans to monitor their progress.

The study will compare the outcomes of these two groups to see if the additional therapy offers any benefits.

Eligibility Criteria

Inclusion Criteria

  • Must have colorectal cancer that has spread to up to four areas in the body.
  • Cancer must be confirmed by lab tests and not have certain genetic markers.
  • If cancer has spread to the brain, it must be treated and stable.
  • Primary tumor must be removed or removable by surgery.
  • Must have measurable cancer that can be tracked by scans.
  • Must have received some chemotherapy before joining the study.
  • Must be 18 years or older and in good general health.
  • Must have adequate blood counts and organ function.
  • Women of childbearing age must have a negative pregnancy test and agree to use birth control.
  • Must not be pregnant or breastfeeding.
  • Must not be planning to take other experimental treatments during the study.

Exclusion Criteria

  • N/A

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