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

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

Proton alone therapy is performed

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

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer
• Intervention / Treatment: Radiation: curative proton therapy

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 Type: Interventional
• Enrollment (Anticipated): 30
• 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

• Korea, Republic of
  • 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: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: National Cancer Center, Korea
• Investigators: Principal Investigator: Dae Yong Kim, M.D., National Cancer Center Korea(South Korea)

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: June 24, 2018
• First Submitted That Met QC Criteria: June 24, 2018
• First Posted (Actual): July 5, 2018

Study Record Updates

• Last Update Posted (Actual): August 21, 2019
• Last Update Submitted That Met QC Criteria: August 19, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Liver Metastasis, Curative Proton Beam Therapy
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis
• Other Study ID Numbers: NCC2018-0108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No