Metastatic Liver CancerPhase 4PrometheusNCT00510627
Study Comparing Radio Frequency Ablation Plus Chemotherapy and Chemotherapy Alone in Patients With Secondary Liver Metastases
A Phase 4 study testing Radiofrequency Ablation (RFA) and Chemotherapy in people with Metastatic Liver Cancer and Secondary Liver Cancer, run by Boston Scientific Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine whether patients treated with Radiofrequency Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Liver Cancer, Secondary Liver Cancer, Liver Neoplasm
- What is being tested?
- Radiofrequency Ablation (RFA) and Chemotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2007to Dec 2010
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All subjects must meet the following criteria:
- Subject must have incurable metastatic colorectal cancer with metastatic disease to the liver
- Subject must have extrahepatic metastatic disease, as confirmed by radiographic evidence or surgical/other documentation that cannot be treated by surgery or image guided therapy to an endpoint of no evidence of residual disease by imaging criteria
- Subject has received and, in the opinion of the treating physician, progressed through at least one prior chemotherapy regimen for metastatic disease, or has developed recurrent disease on or within 6 months of completing adjuvant therapy
- At least 50% of the total tumor burden is in the liver, as determined by the treating investigator, and prior to any study specified intervention (resection or ablation).
- Subject must have no more than 10 hepatic tumors remaining after surgical resection, with no tumor exhibiting a unidimensional size greater than 5cm
Show all 19Show fewer
- Subject is medically eligible to receive RFA, as determined by the treating investigator
- Subject is naïve to, and medically eligible (as defined by the treating investigator) to receive, at least one of the following:
- an oxaliplatin containing regimen
- an irinotecan containing regimen
- an anti-EGFR monoclonal antibody-containing regimen (subject must be naïve to both cetuximab and panitumumab)
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1
- Age > 18 years
- Subject life expectancy > 3 months
- International Normalized Ratio (INR) < 2.0
- Platelets > 100 x103/mm3
- Total Bilirubin <1.5mg/dl
- Creatinine level < 2.0 mg/dl
- Must sign an Informed Consent form
Who cannot join
- All subjects who meet any of the following criteria will not be enrolled into the study:
- Subjects's extrahepatic disease is amenable to curative surgical or image guided therapy
- Subject has known brain metastases
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study
- Other serious medical condition(s) (e.g. uncontrolled infection, uncontrolled cardiac disease) that, in the opinion of the treating investigator, would preclude study treatment or impact survival.
- Current or planned treatment with any experimental chemotherapy or biological agents
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
New York University
New York, New York, 10016
About this study
Official title: A Prospective, Randomized, Active-Control, Multi-Center Study Assessing Overall Survival Using Chemotherapy With or Without Impedance-Based Radiofrequency Ablation for Subjects With Colorectal Cancer and Incurable Metastatic Liver Disease, Failing at Least First-Line Chemotherapy
The purpose of this study is to determine whether patients treated with Radiofrequency Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone.
Read the detailed description
The American Cancer Society has estimated that colorectal cancer is the second leading cause of cancer related deaths, with 106,370 new cases diagnosed in 2004. Due to the unique nature of the hepatic circulatory system, with preferential portal venous drainage of the gastrointestinal tract, the liver is the most common site for metastatic tumor growth from a colorectal carcinoma. It is estimated that approximately 20% of patients diagnosed with colorectal cancer will present with liver involvement at the time of diagnosis, and 50% of patients will manifest metastatic involvement of the liver following resection of the primary colorectal cancer. Over one half of patients who die of colorectal cancer have liver metastases at autopsy.
The current "gold standard" in the treatment of isolated metastatic liver disease is curative hepatic resection. Only within the last 20 years has surgical resection become a viable option, as in the past it was considered unjustified due to high morbidity and mortality rates. The primary drawback to hepatic resection is the sheer number of patients for whom it is contraindicated. Only 10-20% of patients liver metastases are candidates for surgical resection, owing to factors such as tumor locations, size, extent of disease, and other medical co-morbidities.
Historically, in cases where hepatic resection was contraindicated, systemic chemotherapy was the only alternative treatment. In the last several years an increasing number of hepatic directed therapies have become available such as hepatic artery ligation, radiation, hepatic artery infusion of chemotherapy, chemoembolization, and mechanical ablation of the tumor(s).
One mechanical method of ablation involves the use of radiofrequency thermal technology, also called radiofrequency ablation (RFA). The RFA procedure involves inserting an RF electrode into the center of a hepatic tumor mass under ultrasonic or CT guidance. Radiofrequency energy is then applied through the electrode, causing a thermal injury to the surrounding tumor tissue. Currently there are two basic designs for monitoring inter-procedural progress during RFA; temperature monitoring of set points within the target tissue with thermocouples, or assessing the system-wide impedance of tissue adjacent to the deployed electrode tines. Radiofrequency ablation systems are comprised of three components: a radiofrequency generator, an active electrode, and dispersive electrodes.
To date no prospective multi-center trials have been completed which would conclusively demonstrate whether RFA is an effective adjunct to systemic chemotherapy with respect to advantages in median overall survival compared with chemotherapy alone. The primary objective of this trial is to determine overall survival for subjects with colorectal cancer and incurable metastatic liver disease who fail at least first line chemotherapy and are treated with radiofrequency ablation plus additional chemotherapy, compared to subjects receiving additional chemotherapy only.
- Being tested
- Radiofrequency Ablation (RFA), Chemotherapy
- Keywords
- Metastatic Liver Cancer, Colorectal Cancer, Radiofrequency Ablation, Chemotherapy
- Medical subject headings
- Liver Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency Ablation (RFA)Device
Also called RF3000 Radiofrequency (RF) Generators, LeVeen Electrode, Co-Access Electrode, Soloist Electrode
The RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue.
ChemotherapyDrug
Also called Oxaliplatin containing chemotherapy regimen, Irinotecan containing chemotherapy regimen, An anti-EGFR monoclonal antibody-containing regimen, Other
Standard of care chemotherapy regimen
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Radiofrequency ablation in conjunction with chemotherapy Receives: Device: Radiofrequency Ablation (RFA) |
| B | Active comparator | Standard of care chemotherapy regimen Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone.
Measured: Study duration
Secondary outcomes (2)
To evaluate any unanticipated adverse device effects.
Measured: Two years
To determine if there are differences in the incidence or severity of adverse events in the RFA + chemotherapy arm compared to the chemotherapy only arm.
Measured: Study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startAug 2007
- Study completionDec 2010 (estimated)
Why it stopped: Boston Scientific has decided to close the Study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Metastatic Liver CancerStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Jacqmein, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510627
- Sponsor's protocol ID
- ONC-PM-032006
- Acronym
- Prometheus
- Status last verified
- Mar 2017
- First submitted
- 31 Jul 2007
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Chapter 49, Colon, Rectal, and Anal Cancers. PART VI: THE CARE OF INDIVIDUALS WITH SPECIFIC CANCERS; pp: 1156-1214
Choti MA, Bulkley GB. Management of hepatic metastases. Liver Transpl Surg. 1999 Jan;5(1):65-80. doi: 10.1002/lt.500050113.
PubMed 9873095Cromheecke M, de Jong KP, Hoekstra HJ. Current treatment for colorectal cancer metastatic to the liver. Eur J Surg Oncol. 1999 Oct;25(5):451-63. doi: 10.1053/ejso.1999.0679.
PubMed 10527592Kemeny NE, Atiq OT. Non-surgical treatment for liver metastases. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):593-610. doi: 10.1053/bega.1999.0050.
PubMed 10654922Fong Y. Surgical therapy of hepatic colorectal metastasis. CA Cancer J Clin. 1999 Jul-Aug;49(4):231-55. doi: 10.3322/canjclin.49.4.231.
PubMed 11198884Bowles BJ, Machi J, Limm WM, Severino R, Oishi AJ, Furumoto NL, Wong LL, Oishi RH. Safety and efficacy of radiofrequency thermal ablation in advanced liver tumors. Arch Surg. 2001 Aug;136(8):864-9. doi: 10.1001/archsurg.136.8.864.
PubMed 11485520Berber E, Pelley R, Siperstein AE. Predictors of survival after radiofrequency thermal ablation of colorectal cancer metastases to the liver: a prospective study. J Clin Oncol. 2005 Mar 1;23(7):1358-64. doi: 10.1200/JCO.2005.12.039. Epub 2005 Jan 31.
PubMed 15684312Yoon SS, Tanabe KK. Surgical treatment and other regional treatments for colorectal cancer liver metastases. Oncologist. 1999;4(3):197-208.
PubMed 10394588DeMatteo RP, Fong Y, Blumgart LH. Surgical treatment of malignant liver tumours. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):557-74. doi: 10.1053/bega.1999.0048.
PubMed 10654920Curley SA, Vecchio R. New trends in the surgical treatment of colorectal cancer liver metastases. Tumori. 1998 May-Jun;84(3):281-8. doi: 10.1177/030089169808400301.
PubMed 9678609Dodd GD 3rd, Soulen MC, Kane RA, Livraghi T, Lees WR, Yamashita Y, Gillams AR, Karahan OI, Rhim H. Minimally invasive treatment of malignant hepatic tumors: at the threshold of a major breakthrough. Radiographics. 2000 Jan-Feb;20(1):9-27. doi: 10.1148/radiographics.20.1.g00ja019.
PubMed 10682768Poston GJ. Radiofrequency ablation of colorectal liver metastases: where are we really going? J Clin Oncol. 2005 Mar 1;23(7):1342-4. doi: 10.1200/JCO.2005.10.911. Epub 2005 Jan 31. No abstract available.
PubMed 15684315Pawlik TM, Abdalla EK, Ellis LM, Vauthey JN, Curley SA. Debunking dogma: surgery for four or more colorectal liver metastases is justified. J Gastrointest Surg. 2006 Feb;10(2):240-8. doi: 10.1016/j.gassur.2005.07.027.
PubMed 16455457Tournigand C, Andre T, Achille E, Lledo G, Flesh M, Mery-Mignard D, Quinaux E, Couteau C, Buyse M, Ganem G, Landi B, Colin P, Louvet C, de Gramont A. FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study. J Clin Oncol. 2004 Jan 15;22(2):229-37. doi: 10.1200/JCO.2004.05.113. Epub 2003 Dec 2.
PubMed 14657227Giantonio et. Al. High-dose bevacizumab in combination with FOLFOX4 improves survival in patients with previously treated advanced colorectal cancer: Results from the Eastern Cooperative Oncology Group (ECOG) study E3200
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Active-Control, Multi-Center Study Assessing Overall Survival Using Chemotherapy With or Without Impedance-Based Radiofrequency Ablation for Subjects With Colorectal Cancer and Incurable Metastatic Liver Disease, Failing at Least First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT00510627
- Acronym / sponsor ID
- Prometheus / ONC-PM-032006
- Keywords
- Metastatic Liver Cancer, Colorectal Cancer, Radiofrequency Ablation, Chemotherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Boston Scientific has decided to close the Study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2007
- Study completion
- Dec 2010 (estimated)
- First posted
- 2 Aug 2007 (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.
The purpose of this study is to determine whether patients treated with Radiofrequency Ablation (RFA) in conjunction with chemotherapy have a better overall survival rate than patients treated with chemotherapy alone.
Detailed description
The American Cancer Society has estimated that colorectal cancer is the second leading cause of cancer related deaths, with 106,370 new cases diagnosed in 2004. Due to the unique nature of the hepatic circulatory system, with preferential portal venous drainage of the gastrointestinal tract, the liver is the most common site for metastatic tumor growth from a colorectal carcinoma. It is estimated that approximately 20% of patients diagnosed with colorectal cancer will present with liver involvement at the time of diagnosis, and 50% of patients will manifest metastatic involvement of the liver following resection of the primary colorectal cancer. Over one half of patients who die of colorectal cancer have liver metastases at autopsy.
The current "gold standard" in the treatment of isolated metastatic liver disease is curative hepatic resection. Only within the last 20 years has surgical resection become a viable option, as in the past it was considered unjustified due to high morbidity and mortality rates. The primary drawback to hepatic resection is the sheer number of patients for whom it is contraindicated. Only 10-20% of patients liver metastases are candidates for surgical resection, owing to factors such as tumor locations, size, extent of disease, and other medical co-morbidities.
Historically, in cases where hepatic resection was contraindicated, systemic chemotherapy was the only alternative treatment. In the last several years an increasing number of hepatic directed therapies have become available such as hepatic artery ligation, radiation, hepatic artery infusion of chemotherapy, chemoembolization, and mechanical ablation of the tumor(s).
One mechanical method of ablation involves the use of radiofrequency thermal technology, also called radiofrequency ablation (RFA). The RFA procedure involves inserting an RF electrode into the center of a hepatic tumor mass under ultrasonic or CT guidance. Radiofrequency energy is then applied through the electrode, causing a thermal injury to the surrounding tumor tissue. Currently there are two basic designs for monitoring inter-procedural progress during RFA; temperature monitoring of set points within the target tissue with thermocouples, or assessing the system-wide impedance of tissue adjacent to the deployed electrode tines. Radiofrequency ablation systems are comprised of three components: a radiofrequency generator, an active electrode, and dispersive electrodes.
To date no prospective multi-center trials have been completed which would conclusively demonstrate whether RFA is an effective adjunct to systemic chemotherapy with respect to advantages in median overall survival compared with chemotherapy alone. The primary objective of this trial is to determine overall survival for subjects with colorectal cancer and incurable metastatic liver disease who fail at least first line chemotherapy and are treated with radiofrequency ablation plus additional chemotherapy, compared to subjects receiving additional chemotherapy only.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Radiofrequency Ablation (RFA)Radiofrequency ablation in conjunction with chemotherapy |
| B | Active comparator | Drug: ChemotherapyStandard of care chemotherapy regimen |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subject must have incurable metastatic colorectal cancer with metastatic disease to the liver
- Subject must have extrahepatic metastatic disease, as confirmed by radiographic evidence or surgical/other documentation that cannot be treated by surgery or image guided therapy to an endpoint of no evidence of residual disease by imaging criteria
- Subject has received and, in the opinion of the treating physician, progressed through at least one prior chemotherapy regimen for metastatic disease, or has developed recurrent disease on or within 6 months of completing adjuvant therapy
- At least 50% of the total tumor burden is in the liver, as determined by the treating investigator, and prior to any study specified intervention (resection or ablation).
- Subject must have no more than 10 hepatic tumors remaining after surgical resection, with no tumor exhibiting a unidimensional size greater than 5cm
Key exclusion criteria (7 listed)
- Subjects's extrahepatic disease is amenable to curative surgical or image guided therapy
- Subject has known brain metastases
- Uncorrectable coagulopathy
- Subject is pregnant, nursing, or wishes to become pregnant during the study
- Other serious medical condition(s) (e.g. uncontrolled infection, uncontrolled cardiac disease) that, in the opinion of the treating investigator, would preclude study treatment or impact survival.
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 (RFA)Also: RF3000 Radiofrequency (RF) Generators, LeVeen Electrode, Co-Access Electrode, Soloist ElectrodeThe RF3000 radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue. | Device | A |
| ChemotherapyAlso: Oxaliplatin containing chemotherapy regimen, Irinotecan containing chemotherapy regimen, An anti-EGFR monoclonal antibody-containing regimen, OtherStandard of care chemotherapy regimen | Drug | B |
Primary outcome
To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone.
Time frame: Study duration
2 secondary outcomes
To evaluate any unanticipated adverse device effects.
Time frame: Two years
To determine if there are differences in the incidence or severity of adverse events in the RFA + chemotherapy arm compared to the chemotherapy only arm.
Time frame: Study duration
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- BackgroundChapter 49, Colon, Rectal, and Anal Cancers. PART VI: THE CARE OF INDIVIDUALS WITH SPECIFIC CANCERS; pp: 1156-1214
- Background: PubMed 9873095Choti MA, Bulkley GB. Management of hepatic metastases. Liver Transpl Surg. 1999 Jan;5(1):65-80. doi: 10.1002/lt.500050113.
- Background: PubMed 10527592Cromheecke M, de Jong KP, Hoekstra HJ. Current treatment for colorectal cancer metastatic to the liver. Eur J Surg Oncol. 1999 Oct;25(5):451-63. doi: 10.1053/ejso.1999.0679.
- Background: PubMed 10654922Kemeny NE, Atiq OT. Non-surgical treatment for liver metastases. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):593-610. doi: 10.1053/bega.1999.0050.
- Background: PubMed 11198884Fong Y. Surgical therapy of hepatic colorectal metastasis. CA Cancer J Clin. 1999 Jul-Aug;49(4):231-55. doi: 10.3322/canjclin.49.4.231.
- Background: PubMed 11485520Bowles BJ, Machi J, Limm WM, Severino R, Oishi AJ, Furumoto NL, Wong LL, Oishi RH. Safety and efficacy of radiofrequency thermal ablation in advanced liver tumors. Arch Surg. 2001 Aug;136(8):864-9. doi: 10.1001/archsurg.136.8.864.
- Background: PubMed 15684312Berber E, Pelley R, Siperstein AE. Predictors of survival after radiofrequency thermal ablation of colorectal cancer metastases to the liver: a prospective study. J Clin Oncol. 2005 Mar 1;23(7):1358-64. doi: 10.1200/JCO.2005.12.039. Epub 2005 Jan 31.
- Background: PubMed 10394588Yoon SS, Tanabe KK. Surgical treatment and other regional treatments for colorectal cancer liver metastases. Oncologist. 1999;4(3):197-208.
- Background: PubMed 10654920DeMatteo RP, Fong Y, Blumgart LH. Surgical treatment of malignant liver tumours. Baillieres Best Pract Res Clin Gastroenterol. 1999 Dec;13(4):557-74. doi: 10.1053/bega.1999.0048.
- Background: PubMed 9678609Curley SA, Vecchio R. New trends in the surgical treatment of colorectal cancer liver metastases. Tumori. 1998 May-Jun;84(3):281-8. doi: 10.1177/030089169808400301.
- Background: PubMed 10682768Dodd GD 3rd, Soulen MC, Kane RA, Livraghi T, Lees WR, Yamashita Y, Gillams AR, Karahan OI, Rhim H. Minimally invasive treatment of malignant hepatic tumors: at the threshold of a major breakthrough. Radiographics. 2000 Jan-Feb;20(1):9-27. doi: 10.1148/radiographics.20.1.g00ja019.
- Background: PubMed 15684315Poston GJ. Radiofrequency ablation of colorectal liver metastases: where are we really going? J Clin Oncol. 2005 Mar 1;23(7):1342-4. doi: 10.1200/JCO.2005.10.911. Epub 2005 Jan 31. No abstract available.
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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.
William Jacqmein study director
Boston Scientific Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Radiofrequency Ablation (RFA) and Chemotherapy in people with Metastatic Liver Cancer and Secondary Liver Cancer, run by Boston Scientific Corporation at 2 sites in United States.
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 19 inclusion and 7 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: withdrawn, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate Overall Survival in subjects receiving chemotherapy + RFA compared to chemotherapy alone. (time frame: Study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00510627, which also lists 16 linked publications.
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 3 Mar 2017.