Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

Phase 2

• Conditions: Rectal Cancer, Metastatic
• Interventions: Drug: chemotherapy; Radiation: radiotherapy

• Registration Number: NCT03022734
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-09
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-12
• Study First Posted: 2017-01-16
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-13
• Primary Completion: 2021-01
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
chemotherapy with radiotherapy	chemotherapy	Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
chemotherapy with radiotherapy	radiotherapy	Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy

Primary Outcome Measures

Name	Time	Method
complete resection (R0) rate for rectal and liver lesions	after surgical resection, an average of 24 weeks

Secondary Outcome Measures

Name	Time	Method
Response rate (RECIST V1.1)	8 weeks

Trial Locations

Locations (1)

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of