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

NCT ID: NCT03577665

Last Updated: 2019-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-21

Study Completion Date

2025-12-31

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.

Conditions

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Colorectal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

curative proton therapy

Intervention Type RADIATION

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

Interventions

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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

Intervention Type RADIATION

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role lead

Responsible Party

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DAE YONG KIM

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dae Yong Kim, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center Korea(South Korea)

Locations

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National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Dae Yong Kim, M.D.

Role: CONTACT

+82-31-920-1721

Facility Contacts

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Dae Yong Kim, M.D.

Role: primary

+82-31-920-1721

Other Identifiers

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NCC2018-0108

Identifier Type: -

Identifier Source: org_study_id

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