Colorectal CancerNCT03577665
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
A study testing curative proton therapy in people with Colorectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Proton alone therapy is performed -> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- curative proton therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 May 2018to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
- If there is no other remote metastasis other than liver, or if there is, control is possible
- If there are less than 2 liver 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center Korea
Goyang-si, Gyeonggi-do, 10406
Dae Yong Kim, M.D., +82-31-920-1721, radiopia@ncc.re.kr
About this study
Official title: 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
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- curative proton therapy
- Keywords
- Liver Metastasis, Curative Proton Beam Therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
curative proton therapyRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: curative proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time Frame: up to 2 years
Secondary outcomes (2)
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
Measured: 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.
Measured: documented date of progression or death, up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start21 May 2018
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, DAE YONG KIM, National Cancer Center, Korea
- Investigators
- Dae Yong Kim, M.D., Principal investigator, National Cancer Center Korea(South Korea)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577665
- Sponsor's protocol ID
- NCC2018-0108
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2018
- Last updated
- 21 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03577665
- Acronym / sponsor ID
- NCC2018-0108
- Conditions
- Colorectal Cancer
- Keywords
- Liver Metastasis, Curative Proton Beam Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Cancer Center, KoreaOther government
- Study start
- 21 May 2018 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proton alone therapy is performed
-> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| curative proton therapy | Experimental | Radiation: curative proton therapyPatients 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically diagnosed colon adenocarcinoma in primary or metastatic lesions..
- If there is no other remote metastasis other than liver, or if there is, control is possible
- If there are less than 2 liver 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.)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| curative proton therapyPatients 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 |
Primary outcome
2-year local control ratio of the treated liver area
Time frame: Time Frame: up to 2 years
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
2 secondary outcomes
5-year survival rate of treated patients
Time frame: documented data of death, up to 5 years.
5-year disease-free survival rate of treated patients
Time frame: documented date of progression or death, up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dae Yong Kim, M.D. principal investigator
National Cancer Center Korea(South Korea)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing curative proton therapy in people with Colorectal Cancer, run by National Cancer Center, Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Yong Kim, M.D. (+82-31-920-1721, radiopia@ncc.re.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year local control ratio of the treated liver area (time frame: Time Frame: up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2019.