Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Symptoms and General Pathology

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Neoplasm Metastasis

Kidney Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

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

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Aldesleukin

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

IL-2

SABR dose varying from 8Gy-20Gy in 1-3 fractions

Stereotactic Ablative Body Radiation Therapy

Raquibul Hannan, MD, PhD

In this i-SABR (immunotherapy + Stereotactic Ablative Body Radiation) trial, the stereotactic radiation to multiple metastatic sites is delivered not only to eradicate sites of bulky progressive disease, but also to provide antigen presentation and immune stimulation which is expected to act synergistically when immediately followed by the non-specific immune stimulation provided by treatment with HD IL-2 and thereby increase the response rate and complete response for metastatic clear cell renal cell cancer patients. Both HD IL-2 and SABR are FDA approved therapeutic cancer treatment

High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer

A Phase II Trial of High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy (SABR) for Patients With Metastatic Clear Cell Renal Cell Cancer (mRCC)

Treatment response will be measured using the immune related Response Evaluation Criteria in Solid Tumors (RECIST) criteria (iRECIST) which are a minor modification of RECIST 1.1 for immunotherapy

Overall Survival (OS), which is defined as the time between date of registration and the date of death due to any cause.

Progression Free Survival (PFS), which is defined according to the immune Response Evaluation Criteria in Solid Tumors (iRECIST) as the time between date of registration and the first date of documented disease progression or date of death due to any cause.

Time to Progression (TTP), which is defined as time between date of registration and date of documented progression

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of \> 20% in tumor size.

Median response duration, which is defined as the time between the date a response (CR or PR) was first seen until date of progression

Immune response will be measured using ELISpot assay, T-cell proliferation assay and ELISA.

Adverse events will be determined according to Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Prometheus Laboratories

University of Texas Southwestern Medical Center

Principal Investigator

HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion; SABR dose varying from 8Gy-20Gy in 1-3 fractions.

IL-2: HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion

Stereotactic Ablative Body Radiation Therapy: SABR dose varying from 8Gy-20Gy in 1-3 fractions

Treatment

Age, Continuous

Sex: Female, Male

White

Non-white

Race/Ethnicity, Customized

Dr. Raquibul Hannan

There were 5 patients without measurable disease at baseline and 5 additional patients without 2nd scan to confirm progression. Hence, they were not analyzed.

Response Rate

Overall Survival

Progression Free Survival

This outcome measure was inadvertently added at the time of registration. This is same as progression free survival and measures and reports the exact same thing and is redundant. No separate data was collected from participants for this specific measure.

Time to Progression

Local Control Rate

Median Response Duration

This data were never collected from the participants.

Tumor-specific Immune Response

Number of Participants With Adverse Events

The data were never collected from the participants.

Health-related Quality of Life (HRQoL).

Overall Study

Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction.

Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.

Stereotactic ablative body radiation therapy

Michael Chuong, MD

This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.

Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction

A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)

Number of SABRs that meet the following criteria:

1. Successful completed for each lesion within 3 days of intended treatment
2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion
3. Image guidance verification of treatment delivery within 5 mm of the planned delivery

Number of patients that meet the following criteria:

1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity within 90 days of completing SABR
2. No grade 5 toxicity is attributed to SABR

Change in one-year local control will be assessed according to RECIST 1.1 criteria and will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.

Number of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.

Proportion of participants with a change in acute and late toxicity results who experience acute grade 3 or higher toxicity attributable to SABR will be determined along with the corresponding 95% confidence interval. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR.

Patient-reported quality of life will be determined using the FACT-G survey instrument. Fact-G is a 27-item questionnaire that covers four HR-QOL sub-domains: physical, social, emotional, and function well being. Each question will be scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reverse.

Viewray Inc.

Baptist Health South Florida

Digestive System Diseases

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Hematinics

Liver Extracts

Shona Silvester

Natalie Plant

Paul Keall, PhD

This observational study will investigate the properties of image files standardly collected during radiation therapy treatment in a cross-section of liver cancer patients who received stereotactic ablative body radiation therapy (SABR) after trans-catheter arterial chemo emobilisation (TACE). Specifically, it will determine whether the radio-opaque contrast agents in the image files can be detected by tumour-tracking software (KIM).

* Sites will collect image files from the Cancer Radiation Therapy Systems and the medical records of eligible participants. For patient who do not have implanted markers, research personnel (a radiation oncologist, medical physicist or radiation therapist) will manually outline the visible contrast mass. This outline is considered the 'ground truth' of the location of the contrast mass. To ensure its accuracy, the ground truth contrast mass location will be checked by research personnel from another study site.
* Image and ground truth data collected from 80% of participants will be used by University of Sydney researchers to develop the KIM algorithm to detect and track the radio-opaque contrast agents with sufficient robustness to provide justification for the prospective use of KIM as a real-time image guided radiation therapy tool for liver cancer patients.
* The developed KIM software will be applied by site Medical Physicist(s) to the treatment imaging data from the remaining 20% of participants the images. Tumour positions produced by KIM will be compared with a 'ground truth' manual delineation.

Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy

After study completion, de-identified (non-coded, non-re-identifiable) data may be shared with researchers for further scientific research. Information about data sharing will be provided to study participants in the Patient Information Sheet.

Proportion of images in which kilovoltage intrafraction monitoring software detects contrast agent mass on CBCT and intra-treatment images

Average difference (mm) of location of contrast mass detection on CBCT and treatment images by KIM software compared to the ground truth in each of the horizontal and vertical directions.

Standard deviation difference (mm) of location of contrast mass detection on CBCT and treatment images by KIM software compared to the ground truth in each of the horizontal and vertical directions.

Using the KIM success rate (primary hypothesis) and patient CT imaging features (contrast agent density, size, shape and location, patient size etc) a generalised linear model, or appropriate alternative, will be used to identity univariate and multivariate patient or treatment features that contributed to the success or failure of the KIM method. Selected features will be identified and developed into a model. If the model predicts the likelihood of KIM success in at least 85% of the patients then the study will be deemed to have achieved the hypothesis.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer	NCT01896271	Metastatic Clea...	IL-2 Stereotactic Ab...	18 Years - 99 Years	University of Texas Southwestern Medical Center
Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction	NCT04939246	Metastatic Carc...	Stereotactic ab...	18 Years -	Baptist Health South Florida
High Dose IL-2 and Stereotactic Ablative Body Radiation Therapy for Metastatic Renal Cancer	NCT01896271	Metastatic Clea...	IL-2 Stereotactic Ab...	18 Years - 99 Years	University of Texas Southwestern Medical Center
Radio-opaque Contrast Agents for Liver Cancer Targeting With KIM During Radiation Therapy	NCT05169177	Liver Neoplasm		18 Years -	University of Sydney

Spots Global Cancer Trial Database for stereotactic ablative body radiation therapy