Colorectal Liver MetastasisNCT02399995
Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
An observational study of Colorectal Liver Metastasis, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Liver Metastasis
- What is being tested?
- HRQoL questionnaires.
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 219 participants
- Where
- 7 sitesUnited States
- Study dates
- Mar 2015to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
Study population: All patients scheduled to undergo liver resection who meet the established criteria will be approached for participation in this study during their preoperative visit. Should patients not undergo their liver resection surgery within 30 days of consent they will be excluded and replaced. Patients undergoing a two stage resection will have their time point frozen for up to six months after their initial surgery. If the time before the second stage of their resection exceeds six months, these patients will be excluded and replaced. The time point will restart at the completion of the second time point. If the patient has an incomplete resection without mention of a second stage resection, the patient will be made ineligible, taken off study, and replaced.
Who may be able to join
- Diagnosis of Colorectal cancer liver metastases (CRLM)
- > 18 years of age
- Absence of unresectable extrahepatic disease
- No previous liver surgery for CRLM
- Clinical risk score (CRS) >/= 3 or > 4 tumors
- CRS includes the following variables;
Show all 17Show fewer
- Lymph node positive primary
- Disease free interval <12 months
- CEA level >200ng/mL (highest CEA level within 6 months prior to surgery, not including day of surgery)
- Tumor size > 5cm
- Number of tumors >1(based on most recent scan or pathology before liver resection)
- Each variable is given a score of one and summed to give final CRS
- Clinical risk score (CRS) < 3 with pending variables that cannot be determined preoperatively
- If CRS is still < 3 postoperatively, these patients will be excluded and replaced (inevaluable).
- Ability to read and write in English
- Undergoing liver resection/ ablation for CRLM
- Underwent liver resection/ ablation for CRLM, but not their primary tumors
Who cannot join
- Non-English speaking
- Inability to read and/or write
- International Patients
- Concurrent malignancy (excluding non-melanoma skin cancers)
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Basking Ridge (Consent and Follow up)
Basking Ridge, New Jersey
Memorial Sloan Kettering Commack (Consent and Follow up)
Commack, New York, 11725
Memorial Sloan Kettering Westchester (Consent and Follow Up)
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth (Consent and Follow up)
Middletown, New Jersey, 07748
Memorial Sloan Kettering Bergen (Consent and Follow up)
Montvale, New Jersey, 07645
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Memorial Sloan Kettering Nassau (Consent and follow up)
Uniondale, New York, 11553
About this study
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. The information gained from this study will help the investigators to understand the long-term effects that cancer treatments have on the health related quality of life of patients. This information is of high value and will help doctors talk to patients about the possible effects of their operations. While many patients live a long time after such operations, the studies that have been done do not tell the full story of what patients go through after surgery. This study will help us to understand cancer treatment from the patient's perspective. It will also help cancer patients make better decisions about their treatment options and will help them know what to expect after the operation.
- Conditions
- Colorectal Liver Metastasis
- Being tested
- HRQoL questionnaires.
- Keywords
- Quality of Life, Hepatectomy, 15-057
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRQoL questionnaires.Behavioural
Questionnaires/Forms to be completed preoperatively in clinic with assistance from research study administrator:
- Baseline sociodemographic and clinical variable data sheet (RSA)
- EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
- Baseline disease status and treatment assessment questionnaire Questionnaires/Forms to be completed at first postoperative clinic visit:
- EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
Questionnaires/Forms to be mailed to patients at ± 2 month window at the following time points 6,12,18,24, and 36 months following hepatectomy:
- EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
- Post surgical follow up disease status and treatment assessment questionnaire
- At 8 weeks following the mailing of the initial questionnaire package if no response has been received, research personnel will attempt to contact participants by phone.
| Study group | Role | What they receive |
|---|---|---|
| patients following hepatectomy | Not described Receives: Behavioral: HRQoL questionnaires. |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in the quality of life (QoL)
in patients at high risk of recurrence undergoing hepatectomy to assess health related quality of life (HRQoL) using the EORTC QLQ-C30, QLQ-LMC21 and the EuroQol EQ-5D-5L, in patients at high risk of recurrence undergoing hepatectomy for colorectal liver metastasis and to evaluate global and disease specific changes over time.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasisStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 219 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael D'Angelica, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02399995
- Sponsor's protocol ID
- 15-057
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
- ClinicalTrials.gov ID
- NCT02399995
- Acronym / sponsor ID
- 15-057
- Conditions
- Colorectal Liver Metastasis
- Keywords
- Quality of Life, Hepatectomy, 15-057
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 219 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 26 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. The information gained from this study will help the investigators to understand the long-term effects that cancer treatments have on the health related quality of life of patients. This information is of high value and will help doctors talk to patients about the possible effects of their operations. While many patients live a long time after such operations, the studies that have been done do not tell the full story of what patients go through after surgery. This study will help us to understand cancer treatment from the patient's perspective. It will also help cancer patients make better decisions about their treatment options and will help them know what to expect after the operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients following hepatectomy | – | Behavioral: HRQoL questionnaires. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients scheduled to undergo liver resection who meet the established criteria will be approached for participation in this study during their preoperative visit. Should patients not undergo their liver resection surgery within 30 days of consent they will be excluded and replaced. Patients undergoing a two stage resection will have their time point frozen for up to six months after their initial surgery. If the time before the second stage of their resection exceeds six months, these patients will be excluded and replaced. The time point will restart at the completion of the second time point. If the patient has an incomplete resection without mention of a second stage resection, the patient will be made ineligible, taken off study, and replaced.
Key inclusion criteria (17 listed)
- Diagnosis of Colorectal cancer liver metastases (CRLM)
- > 18 years of age
- Absence of unresectable extrahepatic disease
- No previous liver surgery for CRLM
- Clinical risk score (CRS) >/= 3 or > 4 tumors
Key exclusion criteria (4 listed)
- Non-English speaking
- Inability to read and/or write
- International Patients
- Concurrent malignancy (excluding non-melanoma skin cancers)
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 |
|---|---|---|
| HRQoL questionnaires.Questionnaires/Forms to be completed preoperatively in clinic with assistance from research study administrator: * Baseline sociodemographic and clinical variable data sheet (RSA) * EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS * Baseline disease status and treatment assessment questionnaire Questionnaires/Forms to be completed at first postoperative clinic visit: * EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS Questionnaires/Forms to be mailed to patients at ± 2 month window at the following time points 6,12,18,24, and 36 months following hepatectomy: * EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS * Post surgical follow up disease status and treatment assessment questionnaire * At 8 weeks following the mailing of the initial questionnaire package if no response has been received, research personnel will attempt to contact participants by phone. | Behavioural | patients following hepatectomy |
Primary outcome
changes in the quality of life (QoL)
Time frame: 3 years
in patients at high risk of recurrence undergoing hepatectomy to assess health related quality of life (HRQoL) using the EORTC QLQ-C30, QLQ-LMC21 and the EuroQol EQ-5D-5L, in patients at high risk of recurrence undergoing hepatectomy for colorectal liver metastasis and to evaluate global and disease specific changes over time.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Memorial Sloan Kettering 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.
Michael D'Angelica, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Liver Metastasis, run by Memorial Sloan Kettering Cancer Center at 7 sites 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 17 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
changes in the quality of life (QoL) (time frame: 3 years). 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 14 Apr 2026.