Metastatic Colorectal CarcinomaPhase 2NCT02738606
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
A Phase 2 study testing Chemotherapy, Laboratory Biomarker Analysis and Metastasectomy in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung
- What is being tested?
- Chemotherapy, Laboratory Biomarker Analysis and Metastasectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2016to 5 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To determine a survival benefit of liver resection in patients with resectable liver and unresectable low-volume pulmonary metastases from colorectal cancer.
SECONDARY OBJECTIVES:
- To identify biomarkers in blood and resected liver specimens that correlate with survival, and development of extrahepatic and extrapulmonary metastases.
II. To assess patients' quality-of-life in each treatment arm with serial questionnaires.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: 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.
GROUP II: 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.
Patients are followed up every 3-6 months up to 3 years.
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Recurrent Colorectal Carcinoma, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v7
- Being tested
- Chemotherapy, Laboratory Biomarker Analysis, Metastasectomy, Quality-of-Life Assessment, Therapeutic Conventional Surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General
Laboratory Biomarker AnalysisOther
Correlative studies
MetastasectomyProcedure or surgery
Undergo lung metastasectomy
Quality-of-Life AssessmentOther
Also called Quality of Life Assessment
Ancillary studies
Therapeutic Conventional SurgeryProcedure or surgery
Undergo hepatectomy
| Study group | Role | What they receive |
|---|---|---|
| Group I (surgery, chemotherapy) | Experimental | 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. Receives: Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Metastasectomy; Other: Quality-of-Life Assessment; Procedure: Therapeutic Conventional Surgery |
| Group II (chemotherapy) | Active comparator | 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. Receives: Drug: Chemotherapy; Other: Laboratory Biomarker Analysis; Procedure: Metastasectomy; Other: Quality-of-Life Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Survival
The survival subjects were monitored with protocol defined period --- 3 years after enrollment. Survival counts each Arm (percent of survival rate) and p value of Chi-square test for survival rate comparison are shown.
Measured: From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study start23 Sep 2016
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Why it stopped: \< 75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Metastatic Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Yun S Chun, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738606
- Sponsor's protocol ID
- 2015-1133
- Other IDs
- NCI-2016-00740, 2015-1133
- Status last verified
- Jan 2026
- First submitted
- 12 Apr 2016
- Last updated
- 17 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Phase II Trial of Liver Resection Versus No Surgery in Patients With Liver and Unresectable Pulmonary Metastases From Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02738606
- Acronym / sponsor ID
- 2015-1133
- Conditions
- Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver, Metastatic Malignant Neoplasm in the Lung, Recurrent Colorectal Carcinoma, Resectable Colorectal Carcinoma, Stage IV Colorectal Cancer AJCC v7
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \< 75% participation
- Enrolment
- 29 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 23 Sep 2016 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 14 Apr 2016 (estimated)
- Results
- Posted 17 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVE:
- To determine a survival benefit of liver resection in patients with resectable liver and unresectable low-volume pulmonary metastases from colorectal cancer.
SECONDARY OBJECTIVES:
- To identify biomarkers in blood and resected liver specimens that correlate with survival, and development of extrahepatic and extrapulmonary metastases.
II. To assess patients' quality-of-life in each treatment arm with serial questionnaires.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: 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.
GROUP II: 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.
Patients are followed up every 3-6 months up to 3 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (surgery, chemotherapy) | Experimental | Drug: Chemotherapy, Other: Laboratory Biomarker Analysis, Procedure: Metastasectomy, Other: Quality-of-Life Assessment, Procedure: Therapeutic Conventional SurgeryPatients 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. |
| Group II (chemotherapy) | Active comparator | Drug: Chemotherapy, Other: Laboratory Biomarker Analysis, Procedure: Metastasectomy, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with synchronous or metachronous diagnosis of resectable liver metastases by computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: Chemo, Chemotherapy (NOS), Chemotherapy, Cancer, General | Drug | Group I (surgery, chemotherapy), Group II (chemotherapy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Group I (surgery, chemotherapy), Group II (chemotherapy) |
| MetastasectomyUndergo lung metastasectomy | Procedure or surgery | Group I (surgery, chemotherapy), Group II (chemotherapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Group I (surgery, chemotherapy), Group II (chemotherapy) |
| Therapeutic Conventional SurgeryUndergo hepatectomy | Procedure or surgery | Group I (surgery, chemotherapy) |
Primary outcome
Number of Participants With Survival
Time frame: From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months
The survival subjects were monitored with protocol defined period --- 3 years after enrollment. Survival counts each Arm (percent of survival rate) and p value of Chi-square test for survival rate comparison are shown.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun S Chun principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemotherapy, Laboratory Biomarker Analysis and Metastasectomy in people with Metastatic Colorectal Carcinoma and Metastatic Malignant Neoplasm in the Liver, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Survival (time frame: From the date of randomization to the date of death or the date of last follow-up, approximately 8 years and 11 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.