Try our beta test site

Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 by Shanghai Proton and Heavy Ion Center
Sponsor:
Information provided by (Responsible Party):
Guoliang Jiang, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier:
NCT02802124
First received: June 12, 2016
Last updated: June 18, 2016
Last verified: June 2016
  Purpose
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 Intervention Phase
Hepatocellular Carcinoma
Radiation: carbon-ion radiotherapy alone
Radiation: proton plus carbon-ion radiotherapy
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Trial Evaluating Carbon Ion Radiotherapy for the Treatment of Chinese Hepatocellular Carcinoma

Further study details as provided by Shanghai Proton and Heavy Ion Center:

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

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

Estimated Enrollment: 48
Study Start Date: June 2016
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: carbon-ion radiotherapy
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 alone
Experimental: proton plus carbon-ion radiotherapy

For tumor location which is adjacent to gastrointestine (less than 1 cm).We use proton plus carbon-ion radiotherapy for the treatment of hepatocellular carcinoma.

Four dose levels (proton 50GyE/25Fx+ carbon 15GyE/5Fx,proton 34GyE/17Fx+ carbon 30GyE/10Fx, proton 18GyE/9Fx+ carbon 45GyE/15Fx,carbon 60GyE/20Fx ) are planned within the Phase I part.

Radiation: proton plus carbon-ion radiotherapy

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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;
  2. no clinically distant metastasis;
  3. Child Push score A,technically unresectable, or medically inoperable; maximal tumor size is less than 12 cm;
  4. age ≥ 18 and <80 years of age;
  5. Karnofsky Performance Score ≥ 70;
  6. 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;
  7. Willing to sign the written informed consent; Informed consent must be signed before the enrollment in the trial;

Exclusion Criteria:

  1. Distant metastasis (M1);
  2. maximal tumor size is more than 12 cm;
  3. tumor invading adjacent gastrointestine (T4);
  4. Child push score B or C;
  5. Previous hepatic radiotherapy;
  6. Severe systemic disorders;
  7. 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;
  8. Non conformity of the radiotherapy dose distribution when compared to the dose constraints;
  9. Psychiatric disorders or any other condition that can make unreliable the informed consent;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02802124

Contacts
Contact: Zheng Wang, MD +86-38296666-53609 zheng.wang@sphic.org.cn
Contact: weixiang Qi, MD +86-38296666-53607 weixiang.qi@sphic.org.cn

Locations
China, Shanghai
Shanghai Proton and Heavy Ion Center Recruiting
Shanghai, Shanghai, China, 201321
Contact: zheng wang, MD    +86-021-38296666-53609    zheng.wang@sphic.org.cn   
Contact: weixiang Qi, MD    +86-021-38296666-53609    weixiang.qi@sphic.org.cn   
Principal Investigator: guoliang Jiang, Prof.         
Sponsors and Collaborators
Shanghai Proton and Heavy Ion Center
Investigators
Principal Investigator: guoliang Jiang, Prof. Shanghai Proton and Heavy Ion Center
  More Information

Responsible Party: Guoliang Jiang, Director the committee of clinical technique, Shanghai Proton and Heavy Ion Center
ClinicalTrials.gov Identifier: NCT02802124     History of Changes
Other Study ID Numbers: SPHIC-TR-HCC2016-01 
Study First Received: June 12, 2016
Last Updated: June 18, 2016
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Shanghai Proton and Heavy Ion Center:
hepatocellular carcinoma
carbon-ion radiotherapy
toxicity
efficacy

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on February 20, 2017