Clinical trial NCT01978249: A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal cancer
Primary tumor resection
Chemotherapy
Overall survival
Quality of life
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 52
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Short description for lay public, include brief statement of the study hypothesis


Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection
timeFrame: 2 years after allocation
Secondary outcomes:
measure: Analysis of primary tumor related complications in the chemotherapy group and postoperative complications in the primary tumor resection followed by the chemotherapy group.
timeFrame: 2 years after allocation
Other outcomes:
measure: 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.
timeFrame: 2 years after allocation
Locations:
city: Anyang
country: Korea, Republic of
facility: University Sacred Heart Hospital
state: Gyeonggi-do
city: Ilsan
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Incheon
country: Korea, Republic of
facility: Gachon University, Gil Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University, Bundang Hospital
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Yeongnam University Hospital
state: Gyeongsang-do
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeollabukdo
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jeonlla Nam-do
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University, Gangnam Severance Hospital
Study officials:
References:
citation: Kim CW, Baek JH, Choi GS, Yu CS, Kang SB, Park WC, Lee BH, Kim HR, Oh JH, Kim JH, Jeong SY, Ahn JB, Baik SH. The role of primary tumor resection in colorectal cancer patients with asymptomatic, synchronous unresectable metastasis: Study protocol for a randomized controlled trial. Trials. 2016 Jan 19;17:34. doi: 10.1186/s13063-016-1164-0.