Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated:

1. Dose level I: 6 Gy x 5 fractions
2. Dose level II: 8 Gy x 5 fractions
3. Dose level III: 10 Gy x 5 fractions

Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks.

Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations.

Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration).

Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose).

Stereotactic Body Radiation Therapy (SBRT)

Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions.

Microwave Ablation (MWA)

Michael Bassetti

The specific aims of this study are:

1. To determine the safety and feasibility of treating patients with a combination of MRI guided stereotactic body radiation therapy and microwave ablation.
2. To assess short and long-term toxicity rates of patients treated with a combined modality approach.
3. To assess local control, survival, and pathologic response to treatment

Renal cell carcinoma is traditionally managed via a surgical approach. Increasingly, local therapy with radiofrequency and microwave ablation is being utilized as an alternative for patients who may not tolerate a nephrectomy or who refuse one. Although local control rates for small lesions are excellent, they drop off precipitously for lesions over 4 cm. Furthermore, lesions in critical areas such as the renal hilum may be difficult to treat with this method. Stereotactic body radiation therapy (SBRT) has had a long record of treating patients with inoperable tumors in locations such as the lung and central nervous system, and there is increasing evidence that it may be useful for patients with renal cell carcinoma. The recent emergence of MRI-guided radiation therapy allows for direct visualization of tumors during treatment, and may potentially allow clinicians to treat tumors more precisely. This phase I study will treat renal cell carcinoma patients using a combination of MRI-guided stereotactic body radiation therapy and microwave ablation.

Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma

Real-time MRI-Guided Stereotactic Body Radiation Therapy and Microwave Ablation for Non-Operable Renal Cell Carcinoma

Pathologic evaluation for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology

Dose-limiting toxicity (DLT) will be defined as grade 4 or higher non-hematologic toxicity attributable to treatment. This will exclude toxicities not caused by treatment, such as pain due to tumor progression. Toxicities will be defined per NCI CTCAE v5.0.

Radiologic response per RECIST criteria and volumetric measurements.

H\&E staining for percentage of viable tumor remaining as measured by the presence of necrosis, fibrosis, hyalinization, and/or calcification, compared to pre-SBRT pathology

University of Wisconsin, Madison

Radiotherapy & Microwave Ablation

Age, Customized

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Michael Bassetti, MD, PhD

Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma

Local Control Rate Per RECIST Criteria as Reported by Count of Participants

Progression Free Survival

Overall Survival

tumor pathology was not analyzed as study was terminated early, no data collected

Tumor Pathology of Post-SBRT Specimen (H&E Staining)

Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation)

Overall Study

Digestive System Diseases

Carcinoma, Hepatocellular

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.

SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.

Dawn Owen, M.D., Ph.D.

This is a randomized phase II study comparing microwave ablation (MWA) and stereotactic body radiation therapy (SBRT) for localized hepatocellular carcinoma (HCC).

This trial will be the first prospective comparison of these modalities for the treatment of HCC and will provide critical information regarding which local ablative modality is most appropriate for which patients. This study will also provide important information regarding quality of life and liver function changes following these two different treatment modalities.

Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

A Phase II Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma

The primary outcome of this trial is to prospectively determine local control rates in patients with HCC treated with MWA or SBRT. Freedom From Local Progression (FFLP) is defined as the time from randomization to local tumor progression. Tumors falling to group PD (progressive disease) would constitute local control failures. Progressive disease will be defined as at least a 20% increase in the LD (longest diameter) of target lesion, taking as reference the smallest LD recorded. Or at least a 20% increase in viable arterial enhancing disease, taking as reference the smallest LD of viable HCC since treatment started. Increases of less than 3 mm compared to the smallest LD recorded will be considered stable disease rather than PD.

The number of patients experiencing grade 3 or higher GI or hepatobiliary toxicity by Common Terminology Criteria for Adverse Events (CTCAE) v4.0.

The number of patients experiencing a 2 point or more increase in Child-Pugh score and an increase in albumin-bilirubin score of at least 0.5.

The FACT-Hep questionnaire is used to measure health-related quality of life (HRQoL) in patients with hepatobiliary cancers. They are asked questions about their physical, social, emotional and functional well-being and asked to provide a score between 0 and 4 where 0 represents not at all and 4 represents very much.

Overall survival (OS) is defined as the time from randomization to death from any cause. Patients who are alive at last follow-up will be censored on that date.

Progression Free Survival (PFS) is defined as the minimum time to death or any progression.

Metastasis-free survival (MFS) is defined as the minimum time to development of metastases or death, whichever occurs first.

Intrahepatic failure will include progression of the treated lesion(s) as well as development of other new liver lesions.

University of Michigan Rogel Cancer Center

Symptoms and General Pathology

Neoplasm Metastasis

Hematinics

All Drugs and Chemicals

Liver Extracts

Subjects with small renal tumors (SRT) ad described by current ESMO (European Society for Medical Oncology) guidelines who are candidates for MWA

Primary liver tumors: subjects who are candidates for MWA with nodules ≤ 3 cm Liver metastases: subjects who are candidates for MWA with nodules less than ≤ 3 cm

Microwave ablation (MWA)

Francesco De Cobelli, MD

Stephanie Steidler, PhD

Francesco De Cobelli

Paolo Marra, MD

Michele Colombo, MD

The goal of this observational study is to collect data on efficacy and safety of microwave ablation (MWA) used to treat subjects with primary and secondary liver malignancies and renal malignancies. The main question it aims to evaluate the short, medium and long-term clinical course of patients treated with MWA.

Participants will not alter their normal clinical and therapeutic practice, due to the observational nature of the study, and all data regarding microwave treatments will be collected (including demographic data). follow their normal clinical and therapeutic path

Observational, retrospective and prospective, monocentric study. The objective is to evaluate the short, medium and long-term clinical course of patients undergoing microwave ablation (MWA) for small renal tumors and primary and secondary liver neoplasms. Evaluation of clinical efficacy (progression free survival),safety and technical outcome of microwave ablation as well as clinical outcome of the procedure will be evaluated.At the end of the follow-up periods, the data collected will be compared with those available in the literature on MWA, cryoablation (CA), radiofrequency ablation (RFA) and surgical resection.

Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Retrospective and Perspective Analysis of Short, Medium and Long Term Clinical Performance of Patients Undergoing MicrowaveThermal Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms

Based on imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)

Time from ablation to imaging evidence of tumor reccurence at site of ablation (within 5mm of ablation margins)

From date of ablation until death for any cause

From date of ablation until any documented evidence of tumor progression at any site

From date of ablation until any documented evidence of tumor progression at the ablated organ (including reccurence at ablation site)

Professor of Radiology, Clinical and Experimental Radiology

Recurrence

Disease Attributes

Patients receive microwave ablation (MWA)

Patients receive stereotactic body radiotherapy (SBRT)

microwave ablation (MWA) for recurrent small liver cancer

microwave ablation (MWA)

stereotactic body radiotherapy (SBRT) for recurrent small liver cancer

stereotactic body radiotherapy (SBRT)

Qichun Wei, MD,PhD

Yongjie Shui, MM

The prognosis of small liver cancer (≤5 cm) who had underwent stereotactic body radiotherapy (SBRT) is encouraging, with the 1-year local control rate has been reported to be 95-100%, 3-year local control rate about 91%, 3-year overall survival rate around 70%. Local ablation therapy has become the standard treatment for recurrent liver cancer after surgery and interventional treatment. The ablation rate of tumors with a diameter of 3.1-5.0 cm reached 90%. The 1, 2, and 3-year survival rates had been reported to be 89%, 74%, and 60%, respectively, which is similar to that of surgical resection. At present, there is no randomized controlled study of SBRT and microwave ablation (MWA) for small liver cancer. It is hoped that this study will further compare the efficacy of SBRT and MWA for recurrent small hepatocellular carcinoma.

Recurrent small hepatocellular carcinoma after surgery or local ablation therapy are chose for this study. The patients are divided into two groups randomly. Patients in group A receive MWA, group B patients receive SBRT. The 3-year progression free survival, 3-year local recurrence free survival, 3-year overall survival and other endpoints events were recorded and analyzed, to assess whether SBRT is non-inferior to MWA.

Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma

Effects of Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma: a Prospective, Randomized Controlled Study

Progression-free survival (PFS) was measured from the date of MWA or the first fraction of SBRT until the date of first progression (local or distant).

Local recurrence free survival (LRFS) was measured from the date of MWA or the first fraction of SBRT until the date of local recurrence.

Overall survival (OS) was measured from the date of MWA or the first fraction of SBRT until the date of death.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Antineoplastic Agents

Pembrolizumab

Immunomodulating Agents

Chlorotrianisene

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

* Pembrolizumab 200mg IV Q3W on day 1 of cycle 1 and 2
* Radio Frequency Ablation (RFA) / Microwave Ablation (MWA) / brachytherapy or combination of TACE with RFA, MWA or brachytherapy will be performed on day 1 of cycle 3
* Pembrolizumab 200mg IV administration 2 days after local ablation
* Pembrolizumab 200mg IV Q3W for up to 12 months total treatment duration

Local ablation via RFA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center

Radio Frequency Ablation (RFA)

Local ablation via MWA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center

Local ablation via brachythwerapy will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center

Brachytherapy

According to Investigator's choice, TACE using drug eluting beads can be performed combined with RFA, MWA or brachytherapy

Transarterial Chemoembolisation (TACE)

Salah-Eddin Al-Batran, Prof. Dr.

This is a multicenter, single arm, prospective, open-label phase II trial investigating the clinical activity of peri-interventional treatment with the anti-PD1 antibody pembrolizumab in HCC patients who are candidates for local ablation via either radiofrequency ablation (RFA) or microwave ablation (MWA) or brachytherapy or combination of TACE with RFA, MWA or brachytherapy.

The multimodal approach of combining peri-interventional administration of an immune checkpoint inhibitor and local ablation via RFA / MWA / brachytherapy or combination of TACE with RFA, MWA or brachytherapy harbors the potential to satisfy the unmet need for an improvement in the outcomes of HCC patients treated with RFA / MWA/ brachytherapy or combination of TACE with RFA, MWA or brachytherapy. Furthermore, early clinical data indicates that the combination of immune checkpoint inhibition with RFA, MWA or brachytherapy displays an acceptable safety profile, resulting in a positive benefit-risk ratio of this trial.

Immunotherapy with pembrolizumab in combination with local ablation

IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)

IMMULAB - A Phase II Trial of Immunotherapy With Pembrolizumab in Combination With Local Ablation for Patients With Early Stage Hepatocellular Carcinoma (HCC)

Evaluation of ORR according to RECIST 1.1 after two cycles of pembrolizumab and before performing local ablation will allow testing of the hypothesis that pre-interventional treatment with pembrolizumab before local ablation will result in conversion / downstaging of borderline candidates for local ablation. Furthermore, ORR is generally accepted as a valid endpoint for efficacy evaluation in one-armed trials without control group.

TTR and recurrence free survival, have meanwhile been accepted by medicinal agencies in drug approval processes as they allow for quicker efficacy assessment. This is most important in explorative clinical trials in early phases (like this phase II trial) as it allows for more rapid evaluation of the potential of new treatment approaches. Furthermore, many of these parameters are not influenced by follow-up therapies.

Overall survival will be evaluated and is still considered the gold standard for efficacy evaluation in clinical trials. Its major drawback is the potentially long observation period necessary for OS evaluation - especially in the curative setting as represented by the treatment approach in this trial.

Incidence and severity of adverse events according to the current National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)

Correlation analyses between selected molecular parameters and clinical data to identify molecular biomarkers like PD-1, PD-L1 and PD-L2) and immune cell infiltrates (like e.g. IGHM, CD3, CD8, FOXP3, CD68, CD205) as well as chemokines (CXCL9. CXCL10, CXCL13) and invasion markers (MMP7, MMP9) in tumor tissue and blood samples predictive for ORR, TTR, recurrence free survival and OS. Analyses will be performed by immunohistochemical and molecular methods in a central lab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma	NCT02782715	Carcinoma, Rena...	Stereotactic Bo... Microwave Ablat...	18 Years -	University of Wisconsin, Madison
Randomized Trial Comparing Stereotactic Body Radiation Therapy to Microwave Ablation for the Treatment of Localized Hepatocellular Carcinoma	NCT03168152	Carcinoma, Hepa...	Microwave Ablat... Stereotactic Bo...	18 Years -	University of Michigan Rogel Cancer Center
Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms	NCT03981497	Liver Cancer Liver Metastasi... Kidney Cancer Renal Cell Carc...	Microwave ablat...	18 Years -	IRCCS San Raffaele
Stereotactic Body Radiotherapy and Microwave Ablation for Recurrent Small Hepatocellular Carcinoma	NCT03609268	Recurrent Hepat... Microwave Ablat... Stereotactic Bo...	microwave ablat... stereotactic bo...	18 Years - 80 Years	Second Affiliated Hospital, School of Medicine, Zhejiang University
IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)	NCT03753659	Hepatocellular ...	Pembrolizumab Radio Frequency... Microwave Ablat... Brachytherapy Transarterial C...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Microwave Ablation for Treatment of Small Renal Tumors and Primary and Secondary Liver Neoplasms	NCT03981497	Liver Cancer Liver Metastasi... Kidney Cancer Renal Cell Carc...	Microwave ablat...	18 Years -	IRCCS San Raffaele
IMMULAB - Immunotherapy With Pembrolizumab in Combination With Local Ablation in Hepatocellular Carcinoma (HCC)	NCT03753659	Hepatocellular ...	Pembrolizumab Radio Frequency... Microwave Ablat... Brachytherapy Transarterial C...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma	NCT02782715	Carcinoma, Rena...	Stereotactic Bo... Microwave Ablat...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for microwave ablation (mwa)