Surgery + Chemotherapy for Colorectal Cancer

Palo Alto (17 mi)

Overseen byYun S Chun

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This randomized phase II trial studies how well liver surgery and chemotherapy compared to chemotherapy alone work in treating patients with colorectal cancer that has spread to the liver (liver metastases) that can be removed by surgery and that has spread to the lungs (lung metastases) that cannot be removed by surgery. Liver surgery removes a portion of the liver affected by the tumor. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Liver surgery and chemotherapy may work better than chemotherapy alone in treating patients with colorectal cancer which has spread to the liver and lungs.

Eligibility Criteria

This trial is for colorectal cancer patients with liver metastases that can be surgically removed and lung metastases that cannot. Eligible participants may have had previous chemotherapy, have a limited number of small lung nodules, and must be able to undergo imaging tests. Those with additional disease sites, high bilirubin levels, low platelets, poor performance status or who are pregnant cannot join.

Inclusion Criteria

I have liver metastases that can be surgically removed, confirmed by CT or MRI.

My lung scans show 14 or fewer small, smooth nodules under 2 cm without benign features.

My lung cancer cannot be removed surgically due to its location, spread, or my other health issues.

I am eligible for a procedure to remove liver cancer spots smaller than 2 cm.

I have had chemotherapy or biologic treatment for colorectal cancer.

I had surgery or ablation for liver cancer spread from the colon.

Exclusion Criteria

I am mostly bedridden due to my health condition.

I am not pregnant.

I am scheduled for targeted radiation therapy for lung cancer spread.

I do not want to be randomly assigned to a treatment group.

Treatment Details

The study compares the effectiveness of liver surgery combined with chemotherapy versus chemotherapy alone in treating colorectal cancer that has spread to the liver and lungs. It aims to determine if adding surgery improves outcomes for these patients.

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (surgery, chemotherapy)Experimental Treatment5 Interventions

Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.

Group II: Group II (chemotherapy)Active Control4 Interventions

Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.

Chemotherapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Chemotherapy for: