Colorectal Cancer
Conditions
Keywords
Liver Metastasis, Curative Proton Beam Therapy
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.
Interventions
RADIATIONcurative 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
Sponsors
National Cancer Center, Korea
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions.. 2. If there is no other remote metastasis other than liver, or if there is, control is possible 3. If there are less than 2 liver metastatic lesions 4. 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
1. Other histologic cancer other than adenocarcinoma of the colorectal 2. Colorectal cancer without primary lesion resection 3. If there is another remote metastasis and is not completely resected or regulated 4. If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis 5. Pregnancy and women under lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 2-year local control ratio of the treated liver area | Time Frame: up to 2 years | 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
| Measure | Time frame | Description |
|---|---|---|
| 5-year survival rate of treated patients | documented data of death, up to 5 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 5 years |
| 5-year disease-free survival rate of treated patients | documented date of progression or death, up to 5 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 5 years. |
Countries
South Korea
Contacts
Primary ContactDae Yong Kim, M.D.
Outcome results
None listed