Metastatic MelanomaILINCT01920516
Isolated Limb Perfusion of Melphalan for Melanoma and Sarcoma Treatment
An observational study of Metastatic Melanoma, run by International Group of Endovascular Oncology at 1 site in Italy.
Trial summary
In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases are often confined to a limb. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Melanoma
- What is being tested?
- Melphalan
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2013to Jul 2020
- Phase
- Observational
- 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
Study population: primary care clinic
Who may be able to join
- Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection
- Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb
- Bidimensionally measurable disease in the extremity
- Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician
- Age: more than 18
- Karnofsky 70-100%
Show all 11Show fewer
- Life expectancy: At least 6 months
- Hematopoietic: WBC at least 3,000/mm^3
- Renal: Creatinine less than 2.0 mg/dL
- At least 4 weeks since prior antitumor therapy and recovered
- At least 2 weeks since prior antibiotics
Who cannot join
- Signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease)
- pregnant or nursing
- other concurrent serious illness
- severe diabetes
- prior extremity complications due to diabetes
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Azienda Ospedaliera Ospedali Riuniti Marche Nord, Presidio Ospedaliero San Salvatore
Pesaro, PU, 61122
Giammaria Fiorentini, MD, +39072136 ext. 4124, giammaria.fiorentini@ospedalimarchenord.it
Giammaria Fiorentini, MD
About this study
Official title: Prospective Observational Study on Isolated Limb Perfusion of Melphalan in Treating Patients With Metastasis or Recidivism of Limb Melanoma or Sarcoma That Are Not Operable
In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases are often confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma and are generally well tolerated.
ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69% for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these parameters potentially having an effect on outcome. ILP \& ILI are used primarily as palliative options when excision of in-transit metastases is unfeasible but can be used as an adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has been shown to substantially decrease the rates of severe local toxicity while maintaining complete response rates, but overall response rate is reduced.
Read more
Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease is associated with similar complete response rates but lower toxicity than ILI for Lower limbs E disease and with different physiologic sequelae despite comparable methods. The Upper limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently performed, which suggests a potential for further optimization of drug dosing for Upper limbs ILI.
Regional therapy is an excellent therapeutic modality for disease limited to a limb and furthermore serves as an excellent model for scientific investigation, both clinical and translational. In this study we want to collect data on isolated limb infusion of chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the arm or leg that cannot be removed by surgery.
Read the detailed description
This is an observational study and the treatment is related to the experiences and economical availability of each center.
Study Design: Prospective observational study . Primary objective: To collect data on tumor response and progression free survival after administration of melphalan.
Secondary objectives: To collect data on survival rate, time to progression, morbidity tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life (Edmonton questionnaire)
Treatment under observation :
Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity in order to infuse the drug (artery) and to stop the out flow (venous with balloon catheter). Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous balloon catheter. Then the circulation of the limb is blocked with a pneumatic cuff at the root of the limb . Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician.
Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician.
Day -1 Melphalan 1mg/ Kgr has been prepared at Pharmacy.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (25)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) administered by slow drip.
During infusion of the Melphalan into the artery, 1 vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Intra femoral infusion of Melphalan Second ILI treatment could be repeated at side effects recovery ( following oncologist ' s planning of cure).
Day +30: The above procedure is repeated.
Day +90: In case of response, a third administration following the above procedures will be repeated.
Evaluation of response:
Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:
Limb-Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on Response Evaluation Criteria in Solid Tumors (RECIST ) criteria [20-24 ] cancer markers (CEA, cancer antigen (CA) 19.9)
Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.
Assessment of quality of life is performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.
- Conditions
- Metastatic Melanoma
- Being tested
- Melphalan
- Keywords
- Isolated limb infusion, Melphalan, Limb Melanoma, Tumor response
- Medical subject headings
- Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelphalanDrug
Also called Alkeran
Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous baloon catheter.
| Study group | Role | What they receive |
|---|---|---|
| Melphalan | Day +1:
Intra femoral infusion of Melphalan at the dosage 1mg/ Kg
Intra femoral infusion of Melphalan Second ILI treatment can be repeated at side effects recovery ( following oncologist ' s planning of cure).
Day +30: The above procedure is repeated.
Day +90: In case of response, a third administration following the above procedures will be repeated. Receives: Drug: Melphalan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor response
Response must be assessed by repeating the following examinations, at Day 30, Day 90 and Day 120 after start of treatment:
Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on RECIST criteria [18-22 ] cancer markers (CEA, CA 19.9)
Measured: 12 months
Secondary outcomes (3)
survival rate
percentage of patients alive
Measured: 12 months
time to progression
time from treatment start to progression
Measured: 12 months
number of adverse events
number of adverse events
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Metastatic MelanomaStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- International Group of Endovascular Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giammaria Fiorentini, International Group of Endovascular Oncology
- Investigators
- Giammaria Fiorentini, MD, Principal investigator, International Group of Endovascular Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920516
- Sponsor's protocol ID
- ILI01
- Other IDs
- ILI100513
- Acronym
- ILI
- Status last verified
- Feb 2019
- First submitted
- 6 Aug 2013
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ruscitti C, Guadagni S, Russo F, Palumbo G, Fiorentini G, Mambrini A, Cantore M, Kanavos E, Pinto A, Amicucci G. Thoracic stop-flow perfusion for refractory lymphoma: a phase I-II evaluation trial. In Vivo. 2009 May-Jun;23(3):447-57.
PubMed 19454513Guadagni S, Clementi M, Valenti M, Fiorentini G, Cantore M, Kanavos E, Amicucci G. Thoracic stop-flow perfusion in the treatment of refractory malignant pleural mesothelioma: a phase I-II evaluation/trial. In Vivo. 2006 Nov-Dec;20(6A):715-8.
PubMed 17203752Guadagni S, Santinami M, Patuzzo R, Pilati PL, Miotto D, Deraco M, Rossi CR, Fiorentini G, Di Filippo F, Valenti M, Amicucci G. Hypoxic pelvic and limb perfusion with melphalan and mitomycin C for recurrent limb melanoma: a pilot study. Melanoma Res. 2003 Feb;13(1):51-8. doi: 10.1097/00008390-200302000-00009.
PubMed 12569285Guadagni S, Russo F, Rossi CR, Pilati PL, Miotto D, Fiorentini G, Deraco M, Santinami M, Palumbo G, Valenti M, Amicucci G. Deliberate hypoxic pelvic and limb chemoperfusion in the treatment of recurrent melanoma. Am J Surg. 2002 Jan;183(1):28-36. doi: 10.1016/s0002-9610(01)00841-8.
PubMed 11869699Guadagni S, Zoras O, Fiorentini G, Masedu F, Lasithiotakis K, Sarti D, Farina AR, Mackay AR, Clementi M. A Prospective Study of Intraarterial Infusion Chemotherapy in Advanced Wild-Type BRAF Melanoma Patients. J Surg Res. 2021 Dec;268:737-747. doi: 10.1016/j.jss.2021.05.054. Epub 2021 Jul 10.
PubMed 34253376Guadagni S, Fiorentini G, Papasotiriou I, Apostolou P, Masedu F, Sarti D, Farina AR, Mackay AR, Clementi M. Circulating tumour cell liquid biopsy in selecting therapy for recurrent cutaneous melanoma with locoregional pelvic metastases: a pilot study. BMC Res Notes. 2020 Mar 24;13(1):176. doi: 10.1186/s13104-020-05021-5.
PubMed 32204733Guadagni S, Palumbo G, Fiorentini G, Clementi M, Marsili L, Giordano AV, Masedu F, Valenti M. Surgical versus percutaneous isolated pelvic perfusion (IPP) for advanced melanoma: comparison in terms of melphalan pharmacokinetic pelvic bio-availability. BMC Res Notes. 2017 Aug 15;10(1):411. doi: 10.1186/s13104-017-2738-y.
PubMed 28810925
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on Isolated Limb Perfusion of Melphalan in Treating Patients With Metastasis or Recidivism of Limb Melanoma or Sarcoma That Are Not Operable
- ClinicalTrials.gov ID
- NCT01920516
- Acronym / sponsor ID
- ILI / ILI01
- Conditions
- Metastatic Melanoma
- Keywords
- Isolated limb infusion, Melphalan, Limb Melanoma, Tumor response
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- International Group of Endovascular OncologyUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 12 Aug 2013 (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.
In-transit metastases occur in approximately 3% of melanoma patients, can be very symptomatic and the survival in this group may be prolonged. In-transit melanoma metastases are often confined to a limb. In this circumstance, treatment by isolated limb perfusion or isolated limb infusion can be a remarkably effective regional treatment option. Isolated limb infusion (ILI) was introduced in 1992 and is a technique used to deliver regional chemotherapy to treat advanced melanoma confined to a limb. Regional chemotherapy with melphalan delivered by isolated limb perfusion (ILP) or ILI are effective treatment options for in-transit melanoma and are generally well tolerated.
ILI is a less invasive and simpler alternative to ILP. Complete response rates are 45- 69% for ILP and 23-44% for ILI. The limb is often warmed to lower temperatures in ILI compared to ILP and the limb becomes progressively more hypoxic and acidotic during ILI, each of these parameters potentially having an effect on outcome. ILP \& ILI are used primarily as palliative options when excision of in-transit metastases is unfeasible but can be used as an adjunctive procedure to surgery, for other tumour types such as merkel cell carcinoma, and can be repeated if indicated. For ILI correction of melphalan dose for ideal body weight has been shown to substantially decrease the rates of severe local toxicity while maintaining complete response rates, but overall response rate is reduced.
Response to ILI, moreover, is different in upper and lower limbs. ILI for Upper limbs disease is associated with similar complete response rates but lower toxicity than ILI for Lower limbs E disease and with different physiologic sequelae despite comparable methods. The Upper limbs appears relatively resistant to toxic effects of melphalan-based ILI as currently performed, which suggests a potential for further optimization of drug dosing for Upper limbs ILI.
Regional therapy is an excellent therapeutic modality for disease limited to a limb and furthermore serves as an excellent model for scientific investigation, both clinical and translational. In this study we want to collect data on isolated limb infusion of chemotherapy to monitor efficacy and tolerability in patients with melanoma metastases of the arm or leg that cannot be removed by surgery.
Detailed description
This is an observational study and the treatment is related to the experiences and economical availability of each center.
Study Design: Prospective observational study . Primary objective: To collect data on tumor response and progression free survival after administration of melphalan.
Secondary objectives: To collect data on survival rate, time to progression, morbidity tolerability of treatment, number of treatment required to achieve objective response and improvement of quality of life (Edmonton questionnaire)
Treatment under observation :
Patients undergo fluoroscopic placement of angiographic arterial and venous catheters into the appropriate extremity in order to infuse the drug (artery) and to stop the out flow (venous with balloon catheter). Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous balloon catheter. Then the circulation of the limb is blocked with a pneumatic cuff at the root of the limb . Patients with little or no response at 8 weeks may receive up to 2 additional treatments at the discretion of the treating physician.
Patients are followed at 1-2 weeks, 3-4 weeks, 6-8 weeks, and then every 3-6 months thereafter as deemed necessary by the treating physician.
Day -1 Melphalan 1mg/ Kgr has been prepared at Pharmacy.
Day 0: prehydration, antibiotic prophylaxis and setting up of a therapeutic scheme appropriate for analgesic prophylaxis (3-day duration) as previously reported (25)
Day +1:
Upon admittance to the radiology room, 1 vial of tropisetron (diluted in 100ml of physiological solution) administered by slow drip.
During infusion of the Melphalan into the artery, 1 vial of morphine hydrochloride diluted in 100 ml i.v. to be repeated one hour after the procedure and if necessary also after 6 hours.
Tropisetron i.v. if needed. Intra-arterial premedication with 1 vial of verapamil diluted in 4 ml of normal saline solution followed by 4 ml of lidocaine.
Intra femoral infusion of Melphalan Second ILI treatment could be repeated at side effects recovery ( following oncologist ' s planning of cure).
Day +30: The above procedure is repeated.
Day +90: In case of response, a third administration following the above procedures will be repeated.
Evaluation of response:
Response must be assessed by repeating the following examinations at Day 30, Day 90 and Day 120 after start of treatment:
Limb-Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on Response Evaluation Criteria in Solid Tumors (RECIST ) criteria [20-24 ] cancer markers (CEA, cancer antigen (CA) 19.9)
Assessment of quality of life The Edmonton Symptom Assessment System (ESAS) is used to monitor health conditions and quality of life.
Assessment of quality of life is performed during the baseline visit and at Day 30, Day 60 and Day 120 from start of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Melphalan | – | Drug: MelphalanDay +1: Intra femoral infusion of Melphalan at the dosage 1mg/ Kg Intra femoral infusion of Melphalan Second ILI treatment can be repeated at side effects recovery ( following oncologist ' s planning of cure). Day +30: The above procedure is repeated. Day +90: In case of response, a third administration following the above procedures will be repeated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic
Key inclusion criteria (11 listed)
- Histologically proven primary or recurrent, regional melanoma or soft tissue sarcoma that is not amenable to surgical resection
- Majority (greater than 95%) of disease must be distal to the apex of the femoral triangle in the lower limb and the deltoid insertion in the upper limb
- Bidimensionally measurable disease in the extremity
- Patients with disease beyond the limb are eligible if their extremity disease requires palliative treatment in the judgment of their physician
- Age: more than 18
Key exclusion criteria (5 listed)
- Signs or symptoms of vascular insufficiency (no history of claudication or other ischemic peripheral vascular disease)
- pregnant or nursing
- other concurrent serious illness
- severe diabetes
- prior extremity complications due to diabetes
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 |
|---|---|---|
| MelphalanAlso: AlkeranMelphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous baloon catheter. | Drug | Melphalan |
Primary outcome
Tumor response
Time frame: 12 months
Response must be assessed by repeating the following examinations, at Day 30, Day 90 and Day 120 after start of treatment: Chest-abdomen CAT scan with and without contrast medium (refer to Section 4). Evaluation will be based on RECIST criteria [18-22 ] cancer markers (CEA, CA 19.9)
3 secondary outcomes
survival rate
Time frame: 12 months
time to progression
Time frame: 12 months
number of adverse events
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Results publication: PubMed 19454513Ruscitti C, Guadagni S, Russo F, Palumbo G, Fiorentini G, Mambrini A, Cantore M, Kanavos E, Pinto A, Amicucci G. Thoracic stop-flow perfusion for refractory lymphoma: a phase I-II evaluation trial. In Vivo. 2009 May-Jun;23(3):447-57.
- Results publication: PubMed 17203752Guadagni S, Clementi M, Valenti M, Fiorentini G, Cantore M, Kanavos E, Amicucci G. Thoracic stop-flow perfusion in the treatment of refractory malignant pleural mesothelioma: a phase I-II evaluation/trial. In Vivo. 2006 Nov-Dec;20(6A):715-8.
- Results publication: PubMed 12569285Guadagni S, Santinami M, Patuzzo R, Pilati PL, Miotto D, Deraco M, Rossi CR, Fiorentini G, Di Filippo F, Valenti M, Amicucci G. Hypoxic pelvic and limb perfusion with melphalan and mitomycin C for recurrent limb melanoma: a pilot study. Melanoma Res. 2003 Feb;13(1):51-8. doi: 10.1097/00008390-200302000-00009.
- Results publication: PubMed 11869699Guadagni S, Russo F, Rossi CR, Pilati PL, Miotto D, Fiorentini G, Deraco M, Santinami M, Palumbo G, Valenti M, Amicucci G. Deliberate hypoxic pelvic and limb chemoperfusion in the treatment of recurrent melanoma. Am J Surg. 2002 Jan;183(1):28-36. doi: 10.1016/s0002-9610(01)00841-8.
- Derived from this study: PubMed 34253376Guadagni S, Zoras O, Fiorentini G, Masedu F, Lasithiotakis K, Sarti D, Farina AR, Mackay AR, Clementi M. A Prospective Study of Intraarterial Infusion Chemotherapy in Advanced Wild-Type BRAF Melanoma Patients. J Surg Res. 2021 Dec;268:737-747. doi: 10.1016/j.jss.2021.05.054. Epub 2021 Jul 10.
- Derived from this study: PubMed 32204733Guadagni S, Fiorentini G, Papasotiriou I, Apostolou P, Masedu F, Sarti D, Farina AR, Mackay AR, Clementi M. Circulating tumour cell liquid biopsy in selecting therapy for recurrent cutaneous melanoma with locoregional pelvic metastases: a pilot study. BMC Res Notes. 2020 Mar 24;13(1):176. doi: 10.1186/s13104-020-05021-5.
- Derived from this study: PubMed 28810925Guadagni S, Palumbo G, Fiorentini G, Clementi M, Marsili L, Giordano AV, Masedu F, Valenti M. Surgical versus percutaneous isolated pelvic perfusion (IPP) for advanced melanoma: comparison in terms of melphalan pharmacokinetic pelvic bio-availability. BMC Res Notes. 2017 Aug 15;10(1):411. doi: 10.1186/s13104-017-2738-y.
- International group of endovascular oncology (IGEVO) websiteLink provided by the sponsor.
Related trials for Metastatic Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingPhase 1
IL-17 Blockade to Decrease irAEs (REPLAY)
Metastatic Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 1/2
A Study of ST-1898 for Unresectable or Metastatic Melanoma
Unresectable or Metastatic Melanoma
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.
Giammaria Fiorentini, MD principal investigator
International Group of Endovascular Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Melanoma, run by International Group of Endovascular Oncology at 1 site in Italy.
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 11 inclusion and 5 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 27 Feb 2019. 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 Italy. 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.
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 Donatella Sarti, PhD (+39072136 ext. 4018, igevo.datamanager@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor response (time frame: 12 months). 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 NCT01920516, which also lists 7 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 27 Feb 2019.