Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

NCT ID: NCT03022734

Last Updated: 2020-01-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2021-06-30

Brief Summary

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.

Conditions

Rectal Cancer, Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

chemotherapy with radiotherapy

Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy

Group Type: EXPERIMENTAL

chemotherapy

Intervention Type: DRUG

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)

radiotherapy

Intervention Type: RADIATION

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

Interventions

chemotherapy

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)

Intervention Type: DRUG

radiotherapy

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

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Sang Joon Shin

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Joon Shin

Role: CONTACT

82-2-2228-8130

Facility Contacts

Sang Joon Shin

Role: primary

82-2-2228-8130

Other Identifiers

4-2016-0410

Identifier Type: -

Identifier Source: org_study_id