Clinical Study of Effectiveness of Radiotherapy Before Su... | NCT02580929

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

NCT02580929

Sponsor

Peking Union Medical College

Status

Unknown status

Last Update Posted

Oct 22, 2015Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Carcinoma, Hepatocellular

Interventions

radiotherapy

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

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

Oct 2014

Primary Completion Date

Jul 2016Estimated

Completion Date

Jul 2017Estimated

First Submitted Date

Oct 10, 2015

First Submission Date that Met QC Criteria

Oct 18, 2015

First Posted Date

Oct 20, 2015Estimated

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

Oct 21, 2015

Last Update Posted Date

Oct 22, 2015Estimated

Name	Class
Beijing Hope Run	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

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

Detailed Description

Not provided

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

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
radiation	Experimental		Radiation: radiotherapy
no radiation	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
radiotherapy	Radiation	radiotherapy before surgery	radiation

Measure	Description	Time Frame
mortality		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of HCC
In high risk of recurrence of HCC but still can endure palliative resection
KPS scores are >90
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.
Have signed informed consent

Exclusion Criteria:

HCC cannot be operated
With Child-Pugh Class B/C
Have other organ cancer, excluding curative non-melanotic skin cancer and carcinoma in situ of cervix
Have other severe disease
With active hepatitis
Have accepted local radiation therapy in other hospitals
KPS scores≤70
Tumor edges cannot be defined
Have severe cirrhosis complication
Intensity modulated radiation therapy cannot reach required dose
Cannot cooperate
Lactant or pregnant
Cannnot be informed

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
FAN WU	Contact			wufan1011@126.com

Facility	Status	City	State	ZIP	Country	Contacts
WU FAN	Recruiting	Beijing			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36197682	Derived	Wu F, Chen B, Dong D, Rong W, Wang H, Wang L, Wang S, Jin J, Song Y, Liu Y, Fang H, Tang Y, Li N, Zhu X, Li Y, Wang W, Wu J. Phase 2 Evaluation of Neoadjuvant Intensity-Modulated Radiotherapy in Centrally Located Hepatocellular Carcinoma: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Dec 1;157(12):1089-1096. doi: 10.1001/jamasurg.2022.4702.

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type