Impact of Postoperative Adjuvant Chemotherapy in Patients With Hepatocellular Carcinoma After Liver Transplantation

NCT ID: NCT01125020

Last Updated: 2010-05-18

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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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The study is designed to investigate the effect of postoperative adjuvant chemotherapy in prevention of tumor recurrence and metastasis for hepatocellular carcinoma after liver transplantation.

Detailed Description

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Conditions

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Liver Transplantation Hepatocellular Carcinoma Tumor Recurrence and Metastasis Survival Adjuvant Chemotherapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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gemcitabine and oxaliplatin

Group Type ACTIVE_COMPARATOR

gemcitabine and oxaliplatin

Intervention Type DRUG

Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.

doxorubicin, 5-Fu and cisplatin

Group Type ACTIVE_COMPARATOR

doxorubicin, 5-Fu and cisplatin

Intervention Type DRUG

Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.

Interventions

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gemcitabine and oxaliplatin

Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.

Intervention Type DRUG

doxorubicin, 5-Fu and cisplatin

Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All liver transplantation patients with hepatocellular carcinoma between Dec 2008 and May 2010 are potentially eligible for enrollment.

Exclusion Criteria

* Age less than 18 years
* Treatment with other postoperative adjuvant chemotherapy
* Survival is less than 3 months after liver transplantation
* Inability to provide written informed consent prior to study entry
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Changzheng Hospital

OTHER

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Principal Investigators

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Zhi-Hai Peng, MD

Role: STUDY_CHAIR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

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Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jun-Yi Wu, MM

Role: CONTACT

0086-021-63240090 ext. 3136

Facility Contacts

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Zhi-Hai Peng, MD

Role: primary

0086-021-63240090 ext. 3132

References

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Dudek K, Kornasiewicz O, Remiszewski P, Kobryn K, Ziarkiewicz-Wroblewska B, Gornicka B, Zieniewicz K, Krawczyk M. Impact of tumor characteristic on the outcome of liver transplantation in patients with hepatocellular carcinoma. Transplant Proc. 2009 Oct;41(8):3135-7. doi: 10.1016/j.transproceed.2009.08.016.

Reference Type BACKGROUND
PMID: 19857695 (View on PubMed)

Soderdahl G, Backman L, Isoniemi H, Cahlin C, Hockerstedt K, Broome U, Makisalo H, Friman S, Ericzon BG. A prospective, randomized, multi-centre trial of systemic adjuvant chemotherapy versus no additional treatment in liver transplantation for hepatocellular carcinoma. Transpl Int. 2006 Apr;19(4):288-94. doi: 10.1111/j.1432-2277.2006.00279.x.

Reference Type BACKGROUND
PMID: 16573544 (View on PubMed)

Louafi S, Boige V, Ducreux M, Bonyhay L, Mansourbakht T, de Baere T, Asnacios A, Hannoun L, Poynard T, Taieb J. Gemcitabine plus oxaliplatin (GEMOX) in patients with advanced hepatocellular carcinoma (HCC): results of a phase II study. Cancer. 2007 Apr 1;109(7):1384-90. doi: 10.1002/cncr.22532.

Reference Type BACKGROUND
PMID: 17330837 (View on PubMed)

Other Identifiers

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2008BAI60B03

Identifier Type: -

Identifier Source: org_study_id

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