Back to resultsCurative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
Primary Purpose
Colorectal Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
curative proton therapy
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring Liver Metastasis, Curative Proton Beam Therapy
Eligibility Criteria
Inclusion Criteria:
- Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
- If there is no other remote metastasis other than liver, or if there is, control is possible
- If there are less than 2 liver metastatic lesions
- If they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.)
Exclusion Criteria:
- Other histologic cancer other than adenocarcinoma of the colorectal
- Colorectal cancer without primary lesion resection
- If there is another remote metastasis and is not completely resected or regulated
- If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
- Pregnancy and women under lactation
Sites / Locations
- National Cancer Center KoreaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
curative proton therapy
Arm Description
Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
Outcomes
Primary Outcome Measures
2-year local control ratio of the treated liver area
The primary goal of this study is the 2-year local control rate of liver lesions treated with proton therapy. It is judged that the local control rate is improved when the liver metastases of colorectal cancer using conventional X-ray is assumed to have 2-year local control rate of 60% and the 2-year local control rate of proton therapy is set to 80% or more
Secondary Outcome Measures
5-year survival rate of treated patients
To evaluate whether high doses of proton therapy can replace conventional surgical resection. From date of initiation of proton therapy until the date of documented date of death from any cause, assessed up to 5 years
5-year disease-free survival rate of treated patients
To evaluate whether high doses of proton therapy can replace conventional surgical resection. From date of initiation of proton therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Full Information
NCT ID
NCT03577665
First Posted
June 24, 2018
Last Updated
August 19, 2019
Sponsor
National Cancer Center, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03577665
Brief Title
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
Official Title
A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Cancer Center, Korea
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Proton alone therapy is performed
-> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total
Detailed Description
This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for liver metastasis of colorectal cancer diagnosed histologically as adenocarcinoma. Patients who meet the selection criteria should be selected, signed for consent, and treated 5 times a week for 7200 cGy / 15 fractions alone for 3 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Liver Metastasis, Curative Proton Beam Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
curative proton therapy
Arm Type
Experimental
Arm Description
Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
Intervention Type
Radiation
Intervention Name(s)
curative proton therapy
Intervention Description
Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
Primary Outcome Measure Information:
Title
2-year local control ratio of the treated liver area
Description
The primary goal of this study is the 2-year local control rate of liver lesions treated with proton therapy. It is judged that the local control rate is improved when the liver metastases of colorectal cancer using conventional X-ray is assumed to have 2-year local control rate of 60% and the 2-year local control rate of proton therapy is set to 80% or more
Time Frame
Time Frame: up to 2 years
Secondary Outcome Measure Information:
Title
5-year survival rate of treated patients
Description
To evaluate whether high doses of proton therapy can replace conventional surgical resection. From date of initiation of proton therapy until the date of documented date of death from any cause, assessed up to 5 years
Time Frame
documented data of death, up to 5 years.
Title
5-year disease-free survival rate of treated patients
Description
To evaluate whether high doses of proton therapy can replace conventional surgical resection. From date of initiation of proton therapy until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years.
Time Frame
documented date of progression or death, up to 5 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
If there is no other remote metastasis other than liver, or if there is, control is possible
If there are less than 2 liver metastatic lesions
If they refuse lung surgery or surgery is inappropriate (medically unsuitable for surgery due to surgery refusal, diabetes mellitus, high blood pressure, pulmonary disease, heart disease, etc., repeated surgery, poor systematic function, short disease-free period, etc.)
Exclusion Criteria:
Other histologic cancer other than adenocarcinoma of the colorectal
Colorectal cancer without primary lesion resection
If there is another remote metastasis and is not completely resected or regulated
If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
Pregnancy and women under lactation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dae Yong Kim, M.D.
Phone
+82-31-920-1721
Email
radiopia@ncc.re.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dae Yong Kim, M.D.
Organizational Affiliation
National Cancer Center Korea(South Korea)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Cancer Center Korea
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10406
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dae Yong Kim, M.D.
Phone
+82-31-920-1721
Email
radiopia@ncc.re.kr
12. IPD Sharing Statement
Learn more about this trial
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
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