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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03577665
• Other study ID #: NCC2018-0108
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2018
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2019
• Source: National Cancer Center, Korea
• Contact: Dae Yong Kim, M.D.
• Phone: +82-31-920-1721
• Email: radiopia[@]ncc.re.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Proton alone therapy is performed

-> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Neoplasm Metastasis

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
Korea, Republic of	National Cancer Center Korea	Goyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Center, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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