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

Not Applicable

Recruiting

• Conditions: Colorectal Cancer

• Registration Number: NCT03577665
• Lead Sponsor: National Cancer Center, Korea

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.

Study Timeline

• Study Start: 2018-05-21
• Study First Submitted: 2018-06-24
• Study First Submitted QC: 2018-06-24
• Study First Posted: 2018-07-05
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-19
• Last Update Posted: 2019-08-21
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

National Cancer Center Korea; 🇰🇷 Goyang-si, Gyeonggi-do, Korea, Republic of