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

NCT02634502 | Unknown Phase 2 DMC

• 1 other identifier: RFA-2013
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Carcinoma, Pancreatic

Keywords

radiofrequency; chemotherapy; microRNA

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From date of randomization until the date of death, assessed up to 100 months.

Secondary Outcomes (1)

• 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.

Study Arms (1)

Treatment

EXPERIMENTAL

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

Interventions

radiofrequency ablation PROCEDURE

Treatment

S-1 DRUG

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Radiofrequency Ablation; S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Yehua Shen, MD, Ph D

CONTACT

86-21-64175590; yehuash25@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph D

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 18, 2015
• Study Start: October 1, 2013
• Primary Completion: December 1, 2018
• Last Updated: December 18, 2015

Record last verified: 2015-12

Locations

CN (1)