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

NCT03566355 | Unknown DMC

• 1 other identifier: NCC2018-0107
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Proton alone therapy is performed

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

Conditions

Colorectal Cancer

Keywords

Lung Metastasis, Curative Proton Beam Therapy

Outcome Measures

Primary Outcomes (1)

• 3-year local control ratio of the treated lung area

  The primary goal of this study is the 3-year local control rate of pulmonary lesions treated with proton therapy. It is judged that the local control rate is improved when the pulmonary metastases of colorectal cancer using conventional X-ray is assumed to have 3-year local control rate of 60% and the 3-year local control rate of proton therapy is set to 80% or more

  up to 3 years

Secondary Outcomes (2)

• 3-year survival rate of treated patients

  documented data of death, up to 3 years

• 3-year disease-free survival rate of treated patients

  documented date of progression or death, up to 3 years

Study Arms (1)

curative proton therapy

EXPERIMENTAL

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

Interventions

curative proton therapy 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

curative proton therapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
• If there is no other remote metastasis other than lung, or if there is, control is possible
• If there are less than 2 lung metastatic lesions
• 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.)

You may not qualify if:

• Other histologic cancer other than adenocarcinoma of the colorectal
• Colorectal cancer without primary lesion resection
• If there is another remote metastasis and is not completely resected or regulated
• If the patient has experience of other invasive cancer diagnosis within 5 years of colorectal cancer diagnosis
• Pregnancy and women under lactation

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, 10406, South Korea

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Dae Yong Kim, M.D.

  National Cancer Center Korea(South Korea)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Yong Kim, M.D.

CONTACT

82-31-920-1721; radiopia@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 11, 2018
• First Posted: June 25, 2018
• Study Start: May 23, 2018
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 21, 2019

Record last verified: 2019-08

Locations

KR (1)