A Randomized, Prospective, Multicenter Study for the Role of Primary Tumor Resection in Colorectal Cancer Patients With Asymptomatic, Synchronous Unresectable Metastasis

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01978249
• Other study ID #: 4-2013-0277
• Status: Terminated
• Phase: N/A
• Start date: September 2013
• Est. completion date: November 2015

Study information

• Verified date: August 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 52
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Procedure:
• Systemic chemotherapy

• primary tumor resection (PTR)
primary tumor resection (PTR) using open or laparoscopy or robotic surgery

Locations

Country	Name	City	State
Korea, Republic of	University Sacred Heart Hospital	Anyang	Gyeonggi-do
Korea, Republic of	Kyungpook National University Hospital	Daegu
Korea, Republic of	Yeongnam University Hospital	Daegu	Gyeongsang-do
Korea, Republic of	Chonnam National University Hospital	Gwangju	Jeonlla Nam-do
Korea, Republic of	Wonkwang University Hospital	Iksan	Jeollabukdo
Korea, Republic of	National Cancer Center	Ilsan	Gyeonggi-do
Korea, Republic of	Gachon University, Gil Hospital	Incheon	Gyeonggi-do
Korea, Republic of	Seoul National University, Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Yonsei University, Gangnam Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	Comparison of the overall survival between patients who underwent primary tumor resection and patients who received chemotherapy without primary tumor resection	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.	2 years after allocation
Secondary	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