Chemotherapy and/or Metastasectomy in Treating Participants With Metastatic Colorectal Adenocarcinoma With Lung Metastases

Official Title

The Role of Multimodality Management in Risk-Stratified Patients With Lung-Limited Metastatic Colorectal Cancer

Summary:

This phase II trial studies how well chemotherapy and/or metastasectomy work in treating participants with colorectal adenocarcinoma that has spread to the lungs (metastases). Drugs used in chemotherapy work in different ways to stop the growth of tumour cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metastasectomy is a surgical procedure that removes tumours 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 participants with metastatic colorectal adenocarcinoma with lung metastases.

Trial Description

Primary Outcome:

• Recurrence-free survival (Low risk)
• Overall survival (High risk)

PRIMARY OBJECTIVES:

• To compare recurrence-free survival in patients with "low risk" lung-limited metastatic colorectal cancer (mCRC) undergoing pulmonary metastasectomy with or without perioperative chemotherapy.
• To compare overall survival in patients with "high risk" lung-limited mCRC receiving systemic chemotherapy with or without surgical resection.

SECONDARY OBJECTIVES:

• 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:

• To evaluate for changes in circulating tumour deoxyribonucleic acid (DNA) following surgical resection and/or systemic chemotherapy in patients with lung-limited mCRC.

OUTLINE: Participants are assigned to 1 of 2 risk groups (low or high).

GROUP 1 (LOW RISK): Participants are randomized to 1 of 2 groups.

GROUP 1A: Participants 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: Participants undergo metastasectomy.

GROUP 2 (HIGH RISK): All high risk participants receive standard of care chemotherapy for 3 months in the absence of disease progression or unacceptable toxicity. Participants without progressive disease after 3 months are then randomized to 1 of 2 groups.

GROUP 2A: Participants undergo metastasectomy.

GROUP 2B: Participants continue standard of care chemotherapy for 6 months in the absence of disease progression or unacceptable toxicity. Participants with stable disease or radiographic response after 6 months may then cross over to Group 2A. After completion of study treatment, participants are followed up periodically for up to 5 years.

View this trial on ClinicalTrials.gov