Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

Yonsei University40 enrolled

Overview

The purpose of this study is the increase of resection rate of primary cancer in rectal after short course radiotherapy without interrupt chemotherapy schedule during the period of chemotherapy. Radiation therapy is followed by additional chemotherapy to prevent the progression of systemic metastasis, and to reduce the incidence of rectal carcinoma including metastasis.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Rectal Cancer, Metastatic

Interventions

chemotherapyDRUG

cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)

radiotherapyRADIATION

After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * pathologically confirmed for unresectable (impossible to try Total mesorectal excision) rectal cancer with liver metastasis * over 19 years * Eastern Cooperative Oncology Group 0-1 * Proper organ function * more than one target lesion (standard by Response Evaluation Criteria in Solid Tumors 1.1) * Who should sign on the Informed consent form before participate the trial. Exclusion Criteria: * Metastasis in other organ except liver * Chronic active hepatitis or cirrhosis * History of treatment for metastatic colorectal cancer * Subject pregnant or breast feeding * Uncontrolled disease * Have had adjuvant therapy * Uncontrolled peripheral nerve infection * Alcoholic or drug addict * Subject currently is enrolled in or ≤30 days from ending other clinical trial. * History of other type of cancer except resolved from skin cancer and cervical cancer.

Locations (1)

Severance Hospital, Yonsei University Health System

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

complete resection (R0) rate for rectal and liver lesions

Time frame: after surgical resection, an average of 24 weeks

Secondary Outcomes

Response rate (RECIST V1.1)

Time frame: 8 weeks

Central Contacts

Sang Joon Shin

CONTACT

82-2-2228-8130

Data from ClinicalTrials.gov

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