- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03566355
Curative Proton Beam Therapy for Patients With Lung Metastasis of Colorectal Cancer
A Phase II Study of Curative Proton Beam Therapy for Patients With Lung Metastasis of Colorectal Cancer
Proton alone therapy is performed
-> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for pulmonary metastasis of colon 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Dae Yong Kim, M.D.
- Phone Number: 82-31-920-1721
- Email: radiopia@ncc.re.kr
Study Locations
-
-
Gyeonggi-do
-
Goyang-si, Gyeonggi-do, Korea, Republic of, 10406
- Recruiting
- National Cancer Center Korea
-
Contact:
- Dae Yong Kim, M.D.
- Phone Number: 82-31-920-1721
- Email: radiopia@ncc.re.kr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
- If there is no other remote metastasis other than lung, or if there is, control is possible
- If there are less than 2 lung 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: curative proton therapy
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year local control ratio of the treated lung area
Time Frame: up to 3 years
|
The primary goal of this study is the 3-year local control rate of pulmonary lesions treated with proton therapy.
It is judged that the local control rate is improved when the pulmonary metastases of colorectal cancer using conventional X-ray is assumed to have 3-year local control rate of 60% and the 3-year local control rate of proton therapy is set to 80% or more
|
up to 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
3-year survival rate of treated patients
Time Frame: documented data of death, up to 3 years
|
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 3 years
|
documented data of death, up to 3 years
|
3-year disease-free survival rate of treated patients
Time Frame: documented date of progression or death, up to 3 years
|
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 3 years.
|
documented date of progression or death, up to 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dae Yong Kim, M.D., National Cancer Center Korea(South Korea)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCC2018-0107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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