Stereotactic Body Radiotherapy and Microwave Ablation for... | NCT03609268

Studies
Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

NCT03609268

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Status

Unknown status

Last Update Posted

Aug 1, 2018Actual

Enrollment

110Estimated

Phase

Not Applicable

Conditions

Recurrent Hepatocellular Carcinoma
Microwave Ablation
Stereotactic Body Radiotherapy

Interventions

microwave ablation (MWA)
stereotactic body radiotherapy (SBRT)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2018Actual

Primary Completion Date

May 31, 2021Estimated

Completion Date

May 31, 2021Estimated

First Submitted Date

Jul 2, 2018

First Submission Date that Met QC Criteria

Jul 24, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 24, 2018

Last Update Posted Date

Aug 1, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Detailed Description

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MWA	Active Comparator	Patients receive microwave ablation (MWA)	Device: microwave ablation (MWA)
SBRT	Experimental	Patients receive stereotactic body radiotherapy (SBRT)	Radiation: stereotactic body radiotherapy (SBRT)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
microwave ablation (MWA)	Device	microwave ablation (MWA) for recurrent small liver cancer	MWA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival	Progression-free survival (PFS) was measured from the date of MWA or the first fraction of SBRT until the date of first progression (local or distant).	From the date of MWA or the first fraction of SBRT until the date of first progression (local or distant), assessed up to 3 years.

Secondary Outcomes

Measure	Description	Time Frame
local recurrence free survival	Local recurrence free survival (LRFS) was measured from the date of MWA or the first fraction of SBRT until the date of local recurrence.	From the date of MWA or the first fraction of SBRT until the date of local recurrence, assessed up to 3 years
overall survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years old and above.
Clinical or pathological diagnosis of recurrent hepatocellular carcinoma after initial treatment (surgery, TACE, radiofrequency ablation, etc.)
Small hepatocellular carcinoma meeting the Milan criteria: single lesion ≤ 5cm, or tumor number ≤ 3, maximum diameter ≤ 3cm, no major vascular invasion of portal vein, hepatic vein, inferior vena cava, no bile duct invasion, no lymph node and extrahepatic metastasis
No serious blood system, heart, lung, liver, kidney dysfunction and immune deficiency
The neutrophil count is at least 1.0*10^9/ml, and the platelet count is at least 50*10^9/ml. Hemoglobin is at least 80g/L.
Men or women with fertility are willing to take contraceptive measures during the trial
Eastern Cooperative Oncology Group score 0-1 points
Expected survival period > 3 months
Voluntary participation and signing of informed consent

Exclusion Criteria:

Patients who have undergone chemoradiation or targeted therapy for liver cancer
Obvious cirrhosis, recent hematemesis due to portal hypertension, Child-Pugh score ≥10 points
Total bilirubin >70umol/L, aspartate aminotransferase (ALT), alanine aminotransferase (AST) exceed the upper limit of normal 3 times.
Patients undergoing major surgery within 1 month of study initiation
Patients with previous history of malignancy (excludes tumor-free survival after treatment of basal cell carcinoma of the skin and carcinoma of the cervix in situ for more than 3 years)
Researchers consider it inappropriate to participate in the test

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qichun Wei, MD,PhD	Contact	+86 571 87783521		qichun_wei@zju.edu.cn
Yongjie Shui, MM	Contact	+86 571 87783521		shui-yongjie@zju.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
the second affiliated hospital of Zhejiang University	Recruiting	Hangzhou	Zhejiang	310009	China

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008113	Liver Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D004066	Digestive System Diseases
D008107	Liver Diseases

ID	Term
D011878	Radiotherapy
D013812	Therapeutics
D013238	Stereotaxic Techniques
D019635	Neurosurgical Procedures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques