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Anti-tumor antibiotic, Anti-metabolites

Chemotherapy + Surgery for Colorectal Cancer

Phase 2

Waitlist Available

Led By Mara B. Antonoff, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of colorectal metastasis to lung made either histologically with trans-thoracic needle biopsy or clinically based on radiographic imaging

Histological confirmation of colorectal adenocarcinoma

Must not have

Prior intolerance of systemic therapies used as standard regimens in the treatment of metastatic CRC that would prohibit further receipt of systemic chemotherapy and/or biologic agents

Prior therapy with regorafenib or trifluridine/tipiracil (TAS-102) for metastatic/unresectable colorectal cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying if chemotherapy and/or removing tumors from the lungs works well to treat patients with colorectal adenocarcinoma that has spread there.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Chemotherapy can cause side effects like nausea, fatigue, hair loss, increased risk of infection due to low blood cell counts, and potential damage to organs such as the liver or kidneys. Surgical risks include complications from anesthesia, bleeding, infection at the surgery site, and prolonged recovery time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lung cancer diagnosis was confirmed through a biopsy or imaging.

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My diagnosis is colorectal adenocarcinoma.

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My colorectal cancer has spread to my lungs.

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My primary colorectal tumor was surgically removed and there's no sign it has come back.

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My kidney function, measured by creatinine levels or clearance, is within the required range.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot tolerate standard treatments for metastatic colorectal cancer.

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

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I cannot tolerate 5-fluorouracil chemotherapy due to a DPD deficiency.

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I have a type of colon cancer that has not been surgically removed.

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I've had radiotherapy for lung cancer that can still be seen on scans.

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My cancer has spread to other parts of my body and has not been treated yet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall survival (High risk)

Recurrence-free survival (Low risk)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy

2003

Completed Phase 4

~3050

Metastasectomy

2010

N/A

~100