Study on Chemotherapy and Surgery for Treating Colorectal Cancer That Has Spread to the Lungs
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT03599752
This clinical trial is exploring how well chemotherapy and surgery work, either alone or together, in treating patients with colorectal cancer that has spread to the lungs. The study aims to find out if combining these treatments can improve outcomes for patients.
Patient Parameters
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Program Overview
This study is investigating the effectiveness of chemotherapy and a surgical procedure called metastasectomy in treating colorectal cancer that has spread to the lungs. Chemotherapy uses drugs to stop cancer cells from growing, while metastasectomy involves surgically removing tumors that have spread. The study will compare how well these treatments work alone and together in patients with metastatic colorectal cancer affecting the lungs.
Description
The main goals of this study are to compare how long patients remain free of cancer recurrence and overall survival rates between those who undergo surgery with or without chemotherapy and those who receive chemotherapy with or without surgery. The study will also look at the side effects of these treatments and changes in cancer-related DNA in the blood.
Patients will be divided into two groups based on their risk level:
- Low Risk Group: Patients will be randomly assigned to either receive chemotherapy before and after surgery or to have surgery alone.
- High Risk Group: All patients will receive chemotherapy first. Those whose cancer does not progress will then be randomly assigned to either have surgery or continue with chemotherapy.
After completing the study treatment, patients will be monitored periodically for up to five years.
Eligibility Criteria
Inclusion Criteria
- Confirmed diagnosis of colorectal cancer that has spread to the lungs.
- Cancer diagnosis confirmed by biopsy or imaging.
- Suitable candidate for lung surgery as determined by a surgeon.
- Able to undergo chemotherapy as determined by an oncologist.
- Previous treatment of the primary colorectal tumor with no signs of recurrence.
- Good overall health with an ECOG performance status of 0 or 1.
- Ability to provide informed consent.
- Meet specific blood count and organ function criteria.
- Use effective birth control if of childbearing potential.
Exclusion Criteria
- Cancer has spread to other untreated areas like the liver or distant lymph nodes.
- Primary colorectal cancer is still present or has recurred.
- Previous radiation treatment to lung metastases that are still visible.
- Known deficiency that affects chemotherapy tolerance.
- Previous intolerance to standard chemotherapy drugs for colorectal cancer.
- Previous treatment with certain drugs for advanced colorectal cancer.
- Other cancers within the past five years, except for certain skin or in situ cancers.
- Pregnant or breastfeeding women.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Thomas Jefferson University | 19107 | Philadelphia | Pennsylvania |
| Baylor Colllege of Medicine | 77030 | Houston | Texas |
| M D Anderson Cancer Center | 77030 | Houston | Texas |
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