Ignite Creation Date:
2025-12-25 @ 4:52 AM
Ignite Modification Date:
2025-12-26 @ 3:53 AM
Study NCT ID:
NCT01862718
Status:
TERMINATED
Last Update Posted:
2022-08-15
First Post:
2013-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Fusion Guided Thermal Ablation Combined With External Beam Radiation for Hepatic Neoplasms
Status:
TERMINATED
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow/Insufficient accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness
If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded)
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic metastases represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy, or biological therapy for at least 4 weeks prior to starting study treatments, and 4 weeks after treatments Patients must not have an acute, critical illness
If clinical or imaging evidence for cirrhosis present, then Bilirubin must be less than 3 mg/dl and Child-Pugh Classification A, (Class B \& C are excluded)
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Detailed Description:
Background:
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic neoplasms represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy to liver, or biological therapy must have had last dose/ treatment for at least 14 days prior to starting study treatments.
Patients must not have an acute, critical illness
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Pilot study to assess feasibility for combining treatment modalities that should be synergistic (radiation and thermal ablation).
Thermal ablation with Radiofrequency Ablation (RFA) and microwave ablation (MWA) are standard treatments for focal neoplasms in the liver.
High volume or scattered locations of tumor burden results in inability to successfully use this technology for a large proportion of patients with hepatic neoplasms.
Methods to enhance treatment volumes could be advantageous in potentially increasing the indications for thermal ablation or the number of patients benefitting from local ablation.
Primary objective:
To determine the safety of combining 2 standard therapies (thermal ablation and external beam radiation therapy) for liver neoplasms up to 10 cm diameter.
Eligibility:
Patients greater than 18 years of age with pathologically proven unresectable primary or metastatic hepatic neoplasms
Patients whose extent of hepatic neoplasms represents approximately less than 60% of total liver volume AND whose extrahepatic metastatic disease is determined to be minimal
ECOG performance status of less than or equal to 2 and a life expectancy of more than 3 months
Patients with a history of chemotherapy, radiation therapy to liver, or biological therapy must have had last dose/ treatment for at least 14 days prior to starting study treatments.
Patients must not have an acute, critical illness
Design:
Patients will undergo external beam radiation as well as thermal ablation according to standard operating procedures of the NCI and NIH CC.
Patients will be monitored using the standard imaging studies when clinically warranted.
Patients may be treated with a second (or more) thermal ablation procedure ALONE if it is deemed beneficial for the patient by the investigator.
The sample size will be 10 evaluable patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 13-CC-0079 | None | None | View |