Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy

Colorectal Cancer Metastatic Clinical Trial

Official title:

Recovery of Quality of Life After Cytoreductive Surgery and Intraperitoneal Chemotherapy for Colorectal Cancer and Pseudomyxoma Peritonei

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03503071
• Other study ID #: KNUHC03
• Status: Not yet recruiting
• Start date: October 1, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2018
• Source: Kyungpook National University
• Contact: Soo Yeun Park, MD
• Phone: +82-10-8575-9619
• Email: psy-flower[@]daum.net
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer Metastatic
• Colorectal Neoplasms

Intervention

Procedure:
• Cytoreductive surgery and intraperitoneal chemotherapy
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.

Locations

Country	Name	City	State
Korea, Republic of	Kyungpook National University Chilgok Hospital	Daegu

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brief pain inventory (BPI)	Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy	Changes from baseline pain scores at postoperative 12 months
Secondary	European Organisation for Research and Treatment of Cancer (EORTC) Quality of life questionnaire (QLQ)-C30	Qualify of life questionnaire for cancer patients	preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Secondary	EORTC QLQ for colorectal cancer	Quality of life questionnaire for patients with colorectal cancer	preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Secondary	Short-form(SF)-36	Global measure of health-related quality of life	preoperative, postoperative 3 months, postoperative 6 months, postoperative 12 months, postoperative 24 months
Secondary	Postoperative morbidity	Incidence and degree of surgical and medical complications after surgery	90 days after surgery
Secondary	Postoperative mortality	Incidence of postoperative mortality	90 days after surgery
Secondary	Postoperative recovery	Duration of hospital stay after surgery	150 days after surgery
Secondary	Brief pain inventory (BPI)	Pain recovery after cytoreductive surgery and intraperitoneal chemotherapy	preoperative, postoperative 3 months, postoperative 6 months, postoperative 24 months