Hypofractionated Proton Beam Radiotherapy for Hepatocellular Carcinoma

NCT01643824 | Completed

• 1 other identifier: NCCCTS-12-622
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II study is to evaluate the effectiveness of hypofractionated proton beam therapy (PBT) for HCC patients in hepatitis B endemic area.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• local progression-free survival

  To evaluate the local progression-free survival (LPFS) in HCC patients treated with hypofractionated proton beam radiotherapy.

  Up to 1 year

Secondary Outcomes (1)

• overall survival

  Up to 2years until study closed

Study Arms (1)

Proton Beam Therapy

EXPERIMENTAL

* 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

Radiation: Proton Beam Therapy

Interventions

Proton Beam Therapy RADIATION

\- 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

Also known as: Radiotherapy

Proton Beam Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang-si, Gyeonggi-do, 411-769, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Proton Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Heavy Ion Radiotherapy; Therapeutics

Study Officials

• Tae Hyun Kim, Ph.D

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 12, 2012
• First Posted: July 18, 2012
• Study Start: June 7, 2012
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Locations

KR (1)