Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer

Study Overview
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Brief Summary
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Proton alone therapy is performed -> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total

Detailed Description
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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.

Official Title
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A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Radiation: curative proton therapy


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: curative proton therapy<br>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 | Radiation: curative proton therapy<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time Frame: up to 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | documented data of death, 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. | documented date of progression or death, up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Liver Metastasis, Curative Proton Beam Therapy