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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chemotherapy first without primary tumor resection

Patients will receive chemotherapy first without primary tumor resection.

Group Type EXPERIMENTAL

Systemic chemotherapy

Intervention Type PROCEDURE

Primary tumor resection followed by chemotherapy

Patients will receive primary tumor resection followed by chemotherapy.

Group Type ACTIVE_COMPARATOR

primary tumor resection (PTR)

Intervention Type PROCEDURE

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

Interventions

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Systemic chemotherapy

Intervention Type PROCEDURE

primary tumor resection (PTR)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No