Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery

What is the Purpose of this Study?

This study focuses on individuals who have advanced colorectal cancer that has spread up to 4 body sites. The purpose of the study is to compare the usual treatment alone to ablative local therapy (ALT) to all known metastatic tumor sites plus the usual treatment. The usual treatment is treatment with intravenous and/or oral medications (systemic therapy). These medications help stop the cancer sites from getting larger and prevent the spread of the cancer to additional body sites. ALT is commonly used to treat all known tumor sites and may be performed by surgery, radiation therapy, heat with microwave ablation, or other methods. This study will use radiation therapy and potentially surgery and/or heat. To measure the effectiveness of the addition of ALT to treatment, researchers will examine whether this approach increases the life of patients by 17 months or more compared to the usual approach. Participants will be assigned to one of two groups. Group 1 will receive the usual drug therapy used to treat metastatic colorectal cancer plus ALT to all known metastatic sites. Group 2 will receive the usual systemic drug therapy used to treat metastatic colorectal cancer and may also receive palliative local therapies to metastatic sites such as surgery or radiation to help relieve uncontrolled symptoms, such as pain, caused by cancer.


Eligibility

  • * PRE-REGISTRATION (STEP 0): Histologically-confirmed metastatic colorectal adenocarcinoma
  • * PRE-REGISTRATION (STEP 0): No known microsatellite instable (MSI) tumor
  • * PRE-REGISTRATION (STEP 0): No known BRAF V600E mutation
  • * PRE-REGISTRATION (STEP 0): Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. No known peritoneal and/or omental metastases. If radiologic studies suggest the presence of peritoneal disease, a diagnostic laparoscopy is recommended to verify the absence of peritoneal implants
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Where can I participate?

  • CS Cancer at Beverly Hills : Abrahm Levi
  • CS Cancer at Cedars-Sinai Medical Center : Abrahm Levi


More about this Clinical Trial

What is the full name of this clinical trial?

A022101: A Pragmatic Randomized Phase III Trial Evaluating Total Ablative Therapy for Patients with Limited Metastatic Colorectal Cancer: Evaluating Radiation, Ablation, and Surgery

Study Details
Disease Type/Condition

Colon, Rectum

Principal Investigator

Gong, Jun

Co-Investigators

Andrew Hendifar, Arsen Osipov, David Hoffman, Jeremy Lorber, Kevin Scher

Age Group

Adult

Phase

III

IRB Number

STUDY00003115

ClinicalTrials.gov ID

NCT05673148

Key Eligibility
ClinicalTrials.gov

How do I learn more about this study?
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org
Study Detail
Disease Type/Condition

Colon, Rectum

Principal Investigator

Gong, Jun

Age Group

Adult

Phase

III

IRB Number

A022101

ClinicalTrials.gov ID

NCT05673148

Key Eligibility
ClinicalTrials.gov

Contact
Name

Abrahm Levi

Email
Abrahm.Levi@cshs.org