Clinical trial · Interventional
Liver Surgery and Chemotherapy in Treating Patients With Colorectal Cancer With Liver Metastases That Can Be Removed by Surgery and Lung Metastases That Cannot Be Removed by Surgery
Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): \< 75% participation
Summary
Brief summary (as posted)
This randomized phase II trial studies how well liver surgery and chemotherapy compared to chemotherapy alone work in treating patients with colorectal cancer that has spread to the liver (liver metastases) that can be removed by surgery and that has spread to the lungs (lung metastases) that cannot be removed by surgery. Liver surgery removes a portion of the liver affected by the tumor. Chemotherapy drugs 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. Liver surgery and chemotherapy may work better than chemotherapy alone in treating patients with colorectal cancer which has spread to the liver and lungs.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Metastatic Malignant Neoplasm in the Liver | — | UNRESOLVED | — |
| Metastatic Malignant Neoplasm in the Lung | — | UNRESOLVED | — |
| Recurrent Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Resectable Colorectal Carcinoma | Colorectal Carcinoma | CURATED_BROADER | 0.78 |
| Stage IVA Colorectal Cancer AJCC v7 | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Stage IVB Colorectal Cancer AJCC v7 | Malignant Colorectal Neoplasm | CURATED_BROADER |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Metastasectomy | Procedure | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Therapeutic Conventional Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (surgery, chemotherapy)
- description
- Patients undergo hepatectomy and receive chemotherapy at the discretion of treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
- interventionNames
- Drug: Chemotherapy
- Other: Laboratory Biomarker Analysis
- Procedure: Metastasectomy
- Other: Quality-of-Life Assessment
- Procedure: Therapeutic Conventional Surgery
- type
- ACTIVE_COMPARATOR
- label
- Group II (chemotherapy)
- description
- Patients receive chemotherapy at the discretion of the treating oncologist. Patients whose lung tumors become able to be removed by surgery with chemotherapy may undergo lung metastasectomy.
- interventionNames
- Drug: Chemotherapy
- Other: Laboratory Biomarker Analysis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with synchronous or metachronous diagnosis of resectable liver metastases by computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen * Patients requiring percutaneous or intraoperative ablation of liver metastases \< 2 cm in size are eligible * Patients who underwent prior liver resection or ablation for colorectal liver metastases are eligible * Patients previously treated with systemic chemotherapy and/or biologic agents for colorectal cancer are eligible * The primary tumor in the colon or rectum may be intact or resected * Low-volume lung metastases are defined as solid pulmonary nodules \< 2 cm with non-spiculated contours, no benign-appearing calcifications, and =\< 14 in number, diagnosed by computed tomography of the chest or positron emission tomography (PET) * Lung metastases will be unresectable due to anatomic location, distribution, or patients' comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic \& Cardiovascular Surgery * Patients must sign a study-specific consent form * Patients will undergo CT imaging of the chest, abdomen, and pelvis to evaluate lung and liver metastases within 60 days of registration; for patients who cannot tolerate CT contrast or have hepatic steatosis that reduces the sensitivity of CT, MRI of the liver will be performed Exclusion Criteria: * Radiographic evidence of disease other than liver and lungs, with the exception of mediastinal lymph nodes \< 2 cm and hepatoduodenal ligament lymphadenopathy, diagnosed by computed tomography, magnetic resonance imaging, or positron emission tomography * Serum bilirubin \>= 2 mg/dL * Platelet count \< 50,000/uL * Eastern Cooperative Oncology Group (ECOG) performance status of 3-4 * Patient refusal to participate in randomization * Pregnant women are excluded from this study * Planned stereotactic body radiation therapy (SBRT) for the pulmonary metastases
References
Publications (0)
Data not yet available