Chemotherapy + Surgery for Colorectal Cancer

Recruiting in Palo Alto (17 mi)

+9 other locations

Overseen byMara B. Antonoff, MD

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

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well chemotherapy and/or metastasectomy work in treating patients with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy 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. Metastasectomy is a surgical procedure that removes tumors formed from cells that have spread from other places in the body. It is not yet known if chemotherapy and metastasectomy together works better in treating patients with metastatic colorectal adenocarcinoma with lung metastases.

Eligibility Criteria

This trial is for patients with colorectal adenocarcinoma that has spread to the lungs. Candidates must have good lung function, no severe heart disease, and be able to undergo surgery and chemotherapy. They should not have other untreated cancer sites or a history of certain cancers within 5 years, except some skin or in situ cancers.

Inclusion Criteria

My surgeon agrees I can have surgery to remove lung metastases.

I am using effective birth control during this study.

Ability to provide informed consent for participation

+14 more

Exclusion Criteria

I cannot tolerate standard treatments for metastatic colorectal cancer.

I have taken regorafenib or TAS-102 for advanced colorectal cancer.

I have not had cancer other than non-dangerous skin cancer or very early stage cancer in the last 5 years.

+5 more

Participant Groups

The study is examining the effectiveness of combining chemotherapy with a surgical procedure called metastasectomy to remove lung tumors in patients whose colorectal cancer has spread there. It's unclear if using both treatments offers better outcomes than one alone.

4Treatment groups

Experimental Treatment

Group I: Group 2B (chemotherapy)Experimental Treatment1 Intervention

High risk patients continue standard of care chemotherapy for 6 months in the absence of disease progression or unacceptable toxicity. Patients with stable disease or radiographic response after 6 months may then cross over to Group 2A.

Group II: Group 2A (metastasectomy)Experimental Treatment1 Intervention

High risk patients undergo metastasectomy.

Group III: Group 1B (metastasectomy)Experimental Treatment1 Intervention

Low risk patients undergo metastasectomy.

Group IV: Group 1A (chemotherapy, metastasectomy)Experimental Treatment2 Interventions

Low risk patients receive standard of care chemotherapy for 3 months prior to and 3 months after undergoing metastasectomy in the absence of disease progression or unacceptable toxicity.

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

🇪🇺 Approved in European Union as Chemotherapy for: