Finding studies
Finding studies
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Lead
M.D. Anderson Cancer Center
With
PRIMARY OBJECTIVES: I. To compare recurrence-free survival in patients with "low risk" lung-limited metastatic colorectal cancer (mCRC) undergoing pulmonary metastasectomy with or without perioperative chemotherapy. II. To compare overall survival in patients with "high risk" lung-limited mCRC receiving systemic chemotherapy with or without surgical resection. SECONDARY OBJECTIVES: I. To compare grade 3 and 4 adverse events in patients receiving surgical resection and/or chemotherapy in the management of lung-limited mCRC. EXPLORATORY OBJECTIVES: I. To evaluate for changes in circulating tumor deoxyribonucleic acid (DNA) following surgical resection and/or systemic chemotherapy in patients with lung-limited mCRC. OUTLINE: Patients are assigned to 1 of 2 risk groups (low or high). GROUP 1 (LOW RISK): Patients are randomized to 1 of 2 groups. GROUP 1A: 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. GROUP 1B: Patients undergo metastasectomy. GROUP 2 (HIGH RISK): All high risk patients receive standard of care chemotherapy for 3 months in the absence of disease progression or unacceptable toxicity. Patients without progressive disease after 3 months are then randomized to 1 of 2 groups. GROUP 2A: Patients undergo metastasectomy. GROUP 2B: 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. After completion of study treatment, patients are followed up periodically for up to 5 years.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
