Carcinoma, PancreaticPhase 2NCT02634502
Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis
A Phase 2 study testing radiofrequency ablation and S-1 in people with Carcinoma, Pancreatic, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Pancreatic
- What is being tested?
- radiofrequency ablation and S-1
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Oct 2013to Dec 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Yehua Shen, MD, Ph D, 86-21-64175590 ext. 83625, yehuash25@163.com
Hao Chen, MD, Ph D
About this study
Official title: Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis: Correlation Analysis of Prognosis and microRNA Expression
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).
Read the 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.
- Conditions
- Carcinoma, Pancreatic
- Being tested
- radiofrequency ablation, S-1
- Keywords
- radiofrequency, chemotherapy, microRNA
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiofrequency ablationProcedure or surgery
S-1Drug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: radiofrequency ablation; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: From date of randomization until the date of death, assessed up to 100 months.
Secondary outcomes (1)
Progression free survival
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2015 (estimated)
- Study startOct 2013
- Primary completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, PancreaticStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02634502
- Sponsor's protocol ID
- RFA-2013
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 18 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiofrequency Ablation Combined With S-1 for Pancreatic Cancer With Liver Metastasis: Correlation Analysis of Prognosis and microRNA Expression
- ClinicalTrials.gov ID
- NCT02634502
- Acronym / sponsor ID
- RFA-2013
- Conditions
- Carcinoma, Pancreatic
- Keywords
- radiofrequency, chemotherapy, microRNA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2018 (estimated)
- First posted
- 18 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Procedure: radiofrequency ablation, Drug: S-1Patients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| radiofrequency ablation | Procedure or surgery | Treatment |
| S-1 | Drug | Treatment |
Primary outcome
Overall survival
Time frame: From date of randomization until the date of death, assessed up to 100 months.
1 secondary outcome
Progression free survival
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing radiofrequency ablation and S-1 in people with Carcinoma, Pancreatic, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yehua Shen, MD, Ph D (86-21-64175590 ext. 83625, yehuash25@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: From date of randomization until the date of death, assessed up to 100 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2015.