Proton beam therapy for liver metastasis from colorectal cancer
A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
This study tests if proton beam therapy can help people with liver cancer from colorectal cancer feel better when surgery isn't an option for them.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | National Cancer Center, Korea Government |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT03577665 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of curative proton beam therapy specifically for patients with liver metastasis from colorectal cancer, diagnosed as adenocarcinoma. Participants will receive treatment five times a week, totaling 7200 cGy delivered in 15 fractions over three weeks. The study aims to determine if this targeted therapy can improve outcomes for patients who are not suitable for surgical intervention due to various health conditions. It is a prospective, single-organ trial focusing on a specific patient population.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed colon adenocarcinoma and less than two liver metastatic lesions who are not suitable for surgery.
Not a fit: Patients with other types of cancer, those with multiple metastases, or those who have had recent invasive cancer diagnoses may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a non-invasive treatment option for patients with liver metastasis from colorectal cancer, potentially improving survival rates.
How similar studies have performed: While there have been studies on proton therapy for various cancers, this specific approach for liver metastasis from colorectal cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Goyang-si, Gyeonggi-do
- National Cancer Center Korea — Goyang-si, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Dae Yong Kim, M.D. — National Cancer Center Korea(South Korea)
- Study coordinator: Dae Yong Kim, M.D.
- Email: radiopia@ncc.re.kr
- Phone: +82-31-920-1721
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.