Clinical trial · Interventional
Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
A Phase II Study Using Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma
NCT01643824CI-TRIAL-00034552completedN/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)
This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for HCC patients in hepatitis B endemic area.
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 |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Proton Beam Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Proton Beam Therapy
- description
- * Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 6GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume), TLV30 \<40%, and/or RLV30 \<30%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30\<50% and RLV30\<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30\<60%, and/or RLV30\<50% * Dose prescription : 95% isodose volume of prescribed dose encompassed PTV
- interventionNames
- Radiation: Proton Beam Therapy
Primary outcomes (1)
- measure
- local progression-free survival
- timeFrame
- Up to 1 year
- description
- To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * HCC diagnosed as (i) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level greater than 200 IU/ml and a radiologically compatible feature with HCC in one or more CT/MRI/angiograms, or (ii) the presence of risk factors including hepatitis B or C virus and liver cirrhosis, a serum a-fetoprotein (AFP) level less than 200 IU/ml, and a radiologically compatible feature with HCC in two or more CT/MRI/angiograms or (iii) histological confirmation * HCC patients who were not prospective suitable or refused for any other treatment, such as surgery or local ablation therapy, or recurrent or residual tumor after other treatments. * without evidence of extrahepatic metastasis * All target tumors must be encompassable within single irradiation field (15x15 cm maximum) * no previous treatment to target tumors by other forms of RT * liver function of Child-Pugh class A or B7 (Child-Pugh score of ≤7) * Age of ≥18 years * performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score * WBC count ≥ 2,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 25,000/mm3; and adequate hepatic function (total bilirubin ≤ 3.0 mg/dL; AST and ALT \< 5.0× upper limit of normal; no ascites) * no serious comorbidities other than liver cirrhosis * written informed consent Exclusion Criteria: * evidence of extrahepatic metastasis * age \< 18 years * liver function of Child-Pugh class B8-9 and C (Child-Pugh score of \>7) * previous history of other forms of RT adjacent to target tumors * poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score * multicentric HCCs, except for those with the following two conditions: \*multinodular aggregating HCC that could be encompassed by single clinical target volume and within single irradiation field (15x15 cm maximum) \*lesions other than targeted tumor that were judged as controlled with prior surgery and/or local ablation therapy.
References
Publications (0)
Data not yet available
No reference posted for this study.