Clinical Study of Effectiveness of Radiotherapy Before Surgery in High-risk Relapse Hepatocellular Cancer Patients

Carcinoma, Hepatocellular Clinical Trial

Official title:

Effectiveness of Radiotherapy Before Surgery in Patients With High-risk Relapse Hepatocellular Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02580929
• Other study ID #: LC2014B10
• Status: Recruiting
• Phase: N/A
• First received: October 10, 2015
• Last updated: October 21, 2015
• Start date: October 2014
• Est. completion date: July 2017

Study information

• Verified date: October 2015
• Source: Peking Union Medical College
• Contact: FAN WU
• Email: wufan1011[@]126.com
• Is FDA regulated: No
• Health authority: China: Beijing Municipal Health Bureau
• Study type: Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of radiotherapy before surgery in high-risk relapse hepatocellular cancer patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of HCC

2. In high risk of recurrence of HCC but still can endure palliative resection

3. KPS scores are >90

4. With Child-Pugh Class A liver funcion, serum bilirubin< 1.5*normal maxism; ALT and AST< 1.5*normal maxism; normal creatinine and urea nitrogen; WBC>4×109/L, Hb>110g/L, PLT>90X109/L.

5. Have signed informed consent

Exclusion Criteria:

1. HCC cannot be operated

2. With Child-Pugh Class B/C

3. Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix

4. Have other severe disease

5. With active hepatitis

6. Have accepted local radiation therapy in other hospitals

7. KPS scores=70

8. Tumor edges cannot be defined

9. Have severe cirrhosis complication

10. Intensity modulated radiation therapy cannot reach required dose

11. Cannot cooperate

12. Lactant or pregnant

13. Cannnot be informed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular

Intervention

Radiation:
• radiotherapy
radiotherapy before surgery

Locations

Country	Name	City	State
China	WU FAN	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College	Beijing Hope Run

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		5 years	Yes