Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Sponsor

Shanghai Proton and Heavy Ion Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT02802124

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this research project is to assess the feasibility and safety of carbon-ion radiotherapy for the treatment of localized Chinese hepatocellular carcinoma

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma	Radiation: carbon-ion radiotherapy for tumor away from GI Radiation: carbon-ion radiotherapy for tumor adjacent to GI	N/A

Detailed Description

The purpose of this study is to determine the maximal tolerated dose (MTD) of carbon ion radiotherapy (CIRT) in the treatment of localized Chinese hepatocellular carcinoma with respective to toxicity and tumor control. Participants will be treated with CIRT with escalating dose regimens based on the tumor location to evaluate the maximal tolerated dose (MTD) in terms of acute and subacute toxicity observed during and within 3 months after the completion of CIRT. Primary endpoint is toxicity, second endpoint is progression-free survival, overall survival and tumor response.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

48 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Actual Study Start Date :

Jun 1, 2015

Anticipated Primary Completion Date :

Sep 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: carbon-ion radiotherapy for tumor away from GI For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part.	Radiation: carbon-ion radiotherapy for tumor away from GI
Experimental: carbon-ion radiotherapy for tumor adjacent to GI For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.	Radiation: carbon-ion radiotherapy for tumor adjacent to GI

Arm

Intervention/Treatment

Experimental: carbon-ion radiotherapy for tumor away from GI

For tumor location which is away from gastrointestine (the distance is more than 1 cm). We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Four dose levels [55 Gray equivalent (GyE)/10 fractions (Fx), 60GyE/10Fx, 65GyE/10Fx, 70GyE/10Fx] are planned within the Phase I part.

Radiation: carbon-ion radiotherapy for tumor away from GI

Experimental: carbon-ion radiotherapy for tumor adjacent to GI

For tumor location which is adjacent to gastrointestine (less than 1 cm).We use carbon-ion radiotherapy for the treatment of hepatocellular carcinoma. Three dose levels (carbon 60GyE/15Fx, carbon 67.5GyE/15Fx, carbon 75GyE/15Fx) are planned within the Phase I part.

Radiation: carbon-ion radiotherapy for tumor adjacent to GI

Outcome Measures

Primary Outcome Measures

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Time interval from the start of CIRT to 3 months after the completion of CIRT]
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcome Measures

Overall survival of all patients [From the diagnosis of localized hepatocellular carcinoma, a median of 2 years]
Overall survival of all patients
Progression-free survival of all patients [From the diagnosis of localized hepatocellular carcinoma, a median of 2 years]
Progression-free survival of all patients
Number of participants with tumor response as assessed by RECIST 1.1 [Time interval from the start of CIRT to 3 months after the completion of CIRT]
Number of participants with tumor response as assessed by RECIST 1.1

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

histologically confirmed hepatocellular carcinoma (HCC) or clinical diagnosis of HCC according to American association for the study of liver diseases （AASLD）-guidelines or clinical diagnosis criteria based on Alpha Fetoprotein （AFP), and radiological images proposed by Liver Cancer Society, Chinese Anti-Cancer Association;
no clinically distant metastasis;
Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
age ≥ 18 and <80 years of age;
Karnofsky Performance Score ≥ 70;
No previous invasive cancer (within 5 years before the HCC diagnosis)except for skin non-melanoma cancer or non muscle invasive bladder cancer; Ability to understand character and individual consequences of the clinical trial;
Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

Distant metastasis (M1);
maximal tumor size is more than 12 cm;
tumor invading adjacent gastrointestine (T4);
Child push score B or C;
Previous hepatic radiotherapy;
Severe systemic disorders;
Previous malignancy (within 5 years) except for skin non-melanoma cancer or 3-year disease free interval from previous malignancy like in situ cervix cancer or non muscle invasive bladder cancer;
Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
Psychiatric disorders or any other condition that can make unreliable the informed consent;