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

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ClinicalTrials.gov Identifier: NCT03566355
Recruitment Status : Recruiting
First Posted : June 25, 2018
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
DAE YONG KIM, National Cancer Center, Korea

Study Description
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Brief Summary:

Proton alone therapy is performed

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


Condition or disease Intervention/treatment Phase
Colorectal Cancer Radiation: curative proton therapy Not Applicable

Detailed Description:

This clinical trial is a prospective, single-organ, phase II clinical trial to evaluate the efficacy of curative proton therapy for pulmonary metastasis of colon 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Curative Proton Beam Therapy for Patients With Lung Metastasis of Colorectal Cancer
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 3-year local control ratio of the treated lung area [ Time Frame: up to 3 years ]
    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


Secondary Outcome Measures :
  1. 3-year survival rate of treated patients [ Time Frame: documented data of death, up to 3 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 3 years

  2. 3-year disease-free survival rate of treated patients [ Time Frame: documented date of progression or death, up to 3 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 3 years.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
  2. If there is no other remote metastasis other than lung, or if there is, control is possible
  3. If there are less than 2 lung 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03566355


Contacts
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Contact: Dae Yong Kim, M.D. 82-31-920-1721 radiopia@ncc.re.kr

Locations
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Korea, Republic of
National Cancer Center Korea Recruiting
Goyang-si, Gyeonggi-do, Korea, Republic of, 10406
Contact: Dae Yong Kim, M.D.    82-31-920-1721    radiopia@ncc.re.kr   
Sponsors and Collaborators
National Cancer Center, Korea
Investigators
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Principal Investigator: Dae Yong Kim, M.D. National Cancer Center Korea(South Korea)
More Information
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Responsible Party: DAE YONG KIM, Principal Investigator, National Cancer Center, Korea
ClinicalTrials.gov Identifier: NCT03566355    
Other Study ID Numbers: NCC2018-0107
First Posted: June 25, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by DAE YONG KIM, National Cancer Center, Korea:
Lung Metastasis, Curative Proton Beam Therapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes