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Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

Primary Purpose

Rectal Cancer, Metastatic

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
chemotherapy
radiotherapy
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer, Metastatic

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Severance Hospital, Yonsei University Health SystemRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

chemotherapy with radiotherapy

Arm Description

Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy

Outcomes

Primary Outcome Measures

complete resection (R0) rate for rectal and liver lesions

Secondary Outcome Measures

Response rate (RECIST V1.1)

Full Information

First Posted
January 10, 2017
Last Updated
January 10, 2020
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT03022734
Brief Title
Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis
Official Title
A Phase II Study of Neoadjuvant Systemic Chemotherapy With Short Course Radiotherapy in Patients With Unresectable Rectal Cancer and Liver Metastasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
chemotherapy with radiotherapy
Arm Type
Experimental
Arm Description
Cetuximab or Bevacizumab, FOLFOX or FOLFIRI, radiotherapy
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Intervention Description
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
Radiation
Intervention Name(s)
radiotherapy
Intervention Description
After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.
Primary Outcome Measure Information:
Title
complete resection (R0) rate for rectal and liver lesions
Time Frame
after surgical resection, an average of 24 weeks
Secondary Outcome Measure Information:
Title
Response rate (RECIST V1.1)
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang Joon Shin
Phone
82-2-2228-8130
Facility Information:
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Joon Shin
Phone
82-2-2228-8130

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Short Course Radiotherapy, Unresectable Rectal Cancer, Liver Metastasis

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