Clinical trial · Interventional
Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
A Phase II Study of Curative Proton Beam Therapy for Patients With Liver Metastasis of Colorectal Cancer
NCT03577665CI-TRIAL-00040167unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Proton alone therapy is performed -\> 5 times a week, 7200 cGy / 15 fractions for 3 weeks total
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| curative proton therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- curative proton therapy
- description
- 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
- interventionNames
- Radiation: curative proton therapy
Primary outcomes (1)
- measure
- 2-year local control ratio of the treated liver area
- timeFrame
- Time Frame: up to 2 years
- description
- 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
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.