Colorectal Cancer
Conditions
Keywords
Colorectal cancer, Primary tumor resection, Chemotherapy, Overall survival, Quality of life
Brief summary
Short description for lay public, include brief statement of the study hypothesis
Interventions
PROCEDURESystemic chemotherapy
PROCEDUREprimary tumor resection (PTR)
primary tumor resection (PTR) using open or laparoscopy or robotic surgery
Sponsors
Yonsei University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Age : between 20 and 90 years old * Histologically confirmed adenocarcinoma of the colon or the upper rectum * Patients with resectable primary colon or upper rectal cancer and unresectable metastatic lesions. * Patients with no primary cancer related symptoms. * ECOG performance status of 0 - 2 * Appropriate organ functions (hepatic transaminases - less than 5 times the normal range; bilirubin - less than 2 times the normal range; creatinine serum - less than 1.5 times the normal range; thrombocyte - more than 100,000/µl; neutrophil - more than 1,500/µl) * ASA score of \< 3 * An informed consent form has been signed by the patient.
Exclusion criteria
* The patient received adjuvant chemotherapy within the past 6 months. * The patient received chemotherapy for metastatic colon cancer. * The patient was planning to have curative surgery for the metastatic lesions. * The primary cancer is unresectable. * Patients with peritoneal carcinomatosis. * Patients with mid and low rectal cancer (\< 10cm) * Patients with primary tumor related complications such as intestinal obstruction, intractable bleeding, and perforation, that needs to be treated. * ASA score of \> 4 * The patient has chronic hepatitis or cirrhosis. An asymptomatic HBV or HCV carrier can participate. * Patients with an active infection, which need antibiotic therapy, during the randomization period. * Pregnant or breastfeeding women * Patients who were enrolled in another clinical trial during the time of enrollment (within the 28 day randomization period). * Patients with another different malignant tumor during the past 5 years. Patients with treated non-melanoma skin cancer or cervical cancer can be enrolled in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection | 2 years after allocation | Comparison of the overall survival between patients who underwent primary tumor resection followed by chemotherapy and patients who received chemotherapy without primary tumor resection in stage IV colorectal cancer patients with unresectable metastasis. |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group. | 2 years after allocation |
Other
| Measure | Time frame |
|---|---|
| To compare the quality of life between the two groups using the Korean version of EORTC QLQ (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire)-C30. | 2 years after allocation |
Countries
South Korea
Outcome results
None listed