Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

Rectal Cancer, Metastatic Clinical Trial

Official title:

A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03022734
• Other study ID #: 4-2016-0410
• Status: Recruiting
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: June 2021

Study information

• Verified date: January 2020
• Source: Yonsei University
• Contact: Sang Joon Shin
• Phone: 82-2-2228-8130
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rectal Cancer, Metastatic
• Rectal Neoplasms

Intervention

Drug:
• 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)

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

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital, Yonsei University Health System	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
Primary	complete resection (R0) rate for rectal and liver lesions		after surgical resection, an average of 24 weeks
Secondary	Response rate (RECIST V1.1)		8 weeks