Clinical trial NCT03503071: Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy
Official title: Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Colorectal Cancer Metastatic
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients eligible for cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer peritoneal metastasis or pseudomyxoma peritonei

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Palliative surgery
* Palliative intraperitoneal chemotherapy
* Psychotic disorder
* Drug abuser

Primary outcomes:
measure: Brief pain inventory (BPI)
timeFrame: Changes from baseline pain scores at postoperative 12 months
Secondary outcomes:
measure: European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30
timeFrame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
measure: EORTC QLQ for colorectal cancer
timeFrame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
measure: Short-form(SF)-36
timeFrame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
measure: Postoperative morbidity
timeFrame: 90 days after surgery
measure: Postoperative mortality
timeFrame: 90 days after surgery
measure: Postoperative recovery
timeFrame: 150 days after surgery
measure: Brief pain inventory (BPI)
timeFrame: preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Chilgok Hospital
Study officials:
affiliation: Colorectal Cancer Center, Kyungpook National University Chilgok Hospital
name: Soo Yeun Park, MD
role: PRINCIPAL_INVESTIGATOR
References: