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

NCT ID: NCT02580929

Last Updated: 2015-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2017-07-31

Brief Summary

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

Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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radiation

Group Type EXPERIMENTAL

radiotherapy

Intervention Type RADIATION

radiotherapy before surgery

no radiation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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radiotherapy

radiotherapy before surgery

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Hope Run

OTHER

Sponsor Role collaborator

Peking Union Medical College

OTHER

Sponsor Role lead

Responsible Party

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WU FAN

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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WU FAN

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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FAN WU

Role: CONTACT

Facility Contacts

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WU FAN

Role: primary

References

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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.

Reference Type DERIVED
PMID: 36197682 (View on PubMed)

Other Identifiers

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LC2014B10

Identifier Type: -

Identifier Source: org_study_id

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