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

Yonsei University

Status: Terminated

Conditions: Colorectal Cancer

Treatments: Procedure: Systemic chemotherapy; Procedure: primary tumor resection (PTR)

Study type: Interventional

Funder types: Other

Identifiers

NCT01978249

4-2013-0277

Details and patient eligibility

About

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

Enrollment: 52 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Chemotherapy first without primary tumor resection

Experimental group

Description:

Patients will receive chemotherapy first without primary tumor resection.

Treatment:

Procedure: Systemic chemotherapy

Primary tumor resection followed by chemotherapy

Active Comparator group

Description:

Patients will receive primary tumor resection followed by chemotherapy.

Treatment:

Procedure: primary tumor resection (PTR)