Colorectal Cancer MetastaticNCT03503071
Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy
An observational study of Colorectal Cancer Metastatic, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important treatments for patients with colorectal cancer and peritoneal metastasis. For the best survival rates, complete removal of all metastatic lesions is the most important part of treatment, and various surgical procedures are required… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Colorectal Cancer Metastatic
- What is being tested?
- Cytoreductive surgery and intraperitoneal chemotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 31 Dec 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients eligible for cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer peritoneal metastasis or pseudomyxoma peritonei
Who may be able to join
- Colorectal cancer peritoneal metastasis
- Pseudomyxoma peritonei
- ECOG (Eastern Cooperative Oncology Group) performance status 0-3
- Normal bone marrow, kidney, and liver function
- Patient must sign and date the informed consent
Who cannot join
- Palliative surgery
- Palliative intraperitoneal chemotherapy
- Psychotic disorder
- Drug abuser
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Kyungpook National University Chilgok Hospital
Daegu, 41404
About this study
Official title: Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei
Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important treatments for patients with colorectal cancer and peritoneal metastasis. For the best survival rates, complete removal of all metastatic lesions is the most important part of treatment, and various surgical procedures are required for the complete cytoreduction. Therefore, the postoperative morbidity rates are higher than those of localized colon cancer surgeries and patients can experience a prolonged recovery period and deterioration of physical activities over a long period. The aim of this study is to investigate the change of quality of life after cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer.
- Conditions
- Colorectal Cancer Metastatic
- Being tested
- Cytoreductive surgery and intraperitoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytoreductive surgery and intraperitoneal chemotherapyProcedure or surgery
Cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer or pseudomyxoma peritonei. Either early postoperative intraperitoneal chemotherapy (EPIC) or hyperthermic intraperitoneal chemotherapy (HIPEC) is used for intraperitoneal chemotherapy.
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief pain inventory (BPI)
Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy
Measured: Changes from baseline pain scores at postoperative 12 months
Secondary outcomes (7)
European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30
Qualify of life questionnaire for cancer patients
Measured: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
EORTC QLQ for colorectal cancer
Quality of life questionnaire for patients with colorectal cancer
Measured: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Short-form(SF)-36
Global measure of health-related quality of life
Measured: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Postoperative morbidity
Incidence and degree of surgical and medical complications after surgery
Measured: 90 days after surgery
Postoperative mortality
Incidence of postoperative mortality
Measured: 90 days after surgery
Postoperative recovery
Duration of hospital stay after surgery
Measured: 150 days after surgery
Brief pain inventory (BPI)
Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy
Measured: preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2018
- Study start1 Oct 2018 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2025 (estimated)
Why it stopped: protocol change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
- 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
- 0 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soo Yeun Park, Kyungpook National University Hospital
- Investigators
- Soo Yeun Park, MD, Principal investigator, Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03503071
- Sponsor's protocol ID
- KNUHC03
- Status last verified
- Aug 2026
- First submitted
- 9 Apr 2018
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei
- ClinicalTrials.gov ID
- NCT03503071
- Acronym / sponsor ID
- KNUHC03
- Conditions
- Colorectal Cancer Metastatic
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: protocol change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Apr 2018 (actual)
- 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.
Cytoreductive surgery with intraperitoneal chemotherapy is one of the most important treatments for patients with colorectal cancer and peritoneal metastasis. For the best survival rates, complete removal of all metastatic lesions is the most important part of treatment, and various surgical procedures are required for the complete cytoreduction. Therefore, the postoperative morbidity rates are higher than those of localized colon cancer surgeries and patients can experience a prolonged recovery period and deterioration of physical activities over a long period. The aim of this study is to investigate the change of quality of life after cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients eligible for cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer peritoneal metastasis or pseudomyxoma peritonei
Key inclusion criteria (5 listed)
- Colorectal cancer peritoneal metastasis
- Pseudomyxoma peritonei
- ECOG (Eastern Cooperative Oncology Group) performance status 0-3
- Normal bone marrow, kidney, and liver function
- Patient must sign and date the informed consent
Key exclusion criteria (4 listed)
- Palliative surgery
- Palliative intraperitoneal chemotherapy
- Psychotic disorder
- Drug abuser
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 |
|---|---|---|
| Cytoreductive surgery and intraperitoneal chemotherapyCytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer or pseudomyxoma peritonei. Either early postoperative intraperitoneal chemotherapy (EPIC) or hyperthermic intraperitoneal chemotherapy (HIPEC) is used for intraperitoneal chemotherapy. | Procedure or surgery | – |
Primary outcome
Brief pain inventory (BPI)
Time frame: Changes from baseline pain scores at postoperative 12 months
Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy
7 secondary outcomes
European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30
Time frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
EORTC QLQ for colorectal cancer
Time frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Short-form(SF)-36
Time frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Postoperative morbidity
Time frame: 90 days after surgery
Postoperative mortality
Time frame: 90 days after surgery
Postoperative recovery
Time frame: 150 days after surgery
Brief pain inventory (BPI)
Time frame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Soo Yeun Park, MD principal investigator
Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer Metastatic, run by Kyungpook National University Hospital at 1 site in South Korea.
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 5 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: withdrawn, as of the sponsor's last update on 5 Aug 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 South Korea. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Brief pain inventory (BPI) (time frame: Changes from baseline pain scores at postoperative 12 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 5 Aug 2026.