Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis

Sponsor

Fudan University (Other)

Overall Status

Unknown status

CT.gov ID

NCT02634502

Collaborator

(none)

Enrollment

Location

Arm

Study Details

Study Description

Brief Summary

This study aims to explore the efficacy and safety of radiofrequency ablation combined with S-1 in pancreatic cancer patients with liver metastasis, as well as the correlation of serum microRNA and patients' prognosis. This protocol will be overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health & Human Services (Approved: April 25, 2002).

Condition or Disease	Intervention/Treatment	Phase
Carcinoma, Pancreatic	Procedure: radiofrequency ablation Drug: S-1	Phase 2

Detailed Description

Primary Outcome Measures:

To evaluate the overall survival (OS) in pancreatic cancer patients with liver metastasis treated with radiofrequency ablation combined with S-1.

Secondary Outcome Measures:

To explore the correlation of OS and serum microRNA of the patients.
To evaluate the progression free survival (PFS) and its correlation with serum microRNA.
To observe the objective response rate (ORR) and adverse effects of the treatment.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis: Correlation Analysis of Prognosis and microRNA Expression

Study Start Date :

Oct 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Patients will receive radiofrequency ablation for liver metastatic lesions, as well as two weeks of oral S-1 treatment every three weeks, until progression of disease or adverse effects leading to termination of treatment. Each 3-week period is one cycle of treatment.	Procedure: radiofrequency ablation Drug: S-1

Arm

Intervention/Treatment

Experimental: Treatment

Patients will receive radiofrequency ablation for liver metastatic lesions, as well as two weeks of oral S-1 treatment every three weeks, until progression of disease or adverse effects leading to termination of treatment. Each 3-week period is one cycle of treatment.

Procedure: radiofrequency ablation

Drug: S-1

Outcome Measures

Primary Outcome Measures

Overall survival [From date of randomization until the date of death, assessed up to 100 months.]

Secondary Outcome Measures

Progression free survival [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Karnofsky Performance Status ≥ 70
Histologically/cytologically confirmed pancreatic adenocarcinoma.
Patients must have underwent radical resection of the pancreatic lesion, or have their locally advanced pancreatic lesion controlled after first-line chemotherapy.
At least one measurable liver metastasis by RECIST criteria must be present.
Single liver metastasis smaller than 5cm, or multiple liver metastases less than 6 lesions and smaller than 3cm for each, without metastasis to other sites.
Patients must have adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 2,000/uL, Hemoglobin ≥ 8.0 gm/dL, Platelets ≥ 100,000/uL, Serum creatinine < 2.0 mg/dL, Bilirubin < 1.5 mg/dL, SGPT < 2.5 x normal, prothrombin time <13.5s

Prior therapy, e.g., chemotherapy, radiation, is allowed provided that at least 4 weeks washout time is given.
Patients with jaundice must have a biliary drainage decompression operation before recruitment.
Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

Prior treatment with S-1.
Liver metastatic lesion is located at the surface of the liver, with more than 1/3 of the tumor protruding outside.
Subject has Child-Pugh grade Class C hepatic impairment, massive ascites, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected, or other contraindication for radiofrequency ablation.
Tumor invasion of Cavity organs.
Known central nervous system involvement and leptomeningeal disease.
Concurrent infection requiring intravenous antibiotics.
Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
Subject has previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
Pregnant or lactating women.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fudan University Shanghai Cancer Center	Shanghai	Shanghai	China	200032

Sponsors and Collaborators

Fudan University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hao Chen, MD, Ph D, Fudan University

ClinicalTrials.gov Identifier:

NCT02634502

Other Study ID Numbers:

RFA-2013

First Posted:

Dec 18, 2015

Last Update Posted:

Dec 18, 2015

Last Verified:

Dec 1, 2015

Keywords provided by Hao Chen, MD, Ph D, Fudan University

radiofrequency

chemotherapy

microRNA

Study Results

No Results Posted as of Dec 18, 2015