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

Stereotactic ablative body radiation (SAbR) to all sites of measurable metastases (≤3) will be treated by SAbR. New sites of metastasis will be evaluated for continued treatment if deemed appropriate by both medical and radiation oncologists with SAbR.

SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.

Stereotactic ablative body radiation (SABR)

Raquibul Hannan, MD, PhD

Hypothesis:

Stereotactic ablative body radiation (SAbR) prolongs progression-free survival for patients with oligometastatic kidney cancer (RCC) and delays the initiation of systemic therapy.

Primary Objectives:

• To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy.

Secondary Objective:

* To evaluate the modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR.
* To evaluate the overall survival (OS)
* To evaluate the cancer specific survival (CSS)
* To evaluate the local control rate of irradiated lesions.
* To measure the health-related quality of life (HRQOL).

The study is a prospective single institution phase II single-arm open-label trial evaluating SAbR in patients with newly diagnosed oligometastatic RCC.

Problem Statements:

* Can local therapy (SAbR) safely delay the start of systemic therapy?
* Safely delaying the start of systemic therapy can have significant quality of life benefits for patients since systemic therapy has significant side effects.
* Can SAbR be curative in truly oligometastatic RCC patients?

Primary Endpoint:

• Time to start of systemic therapy (TTST) defined as the time from the first day of SAbR to start of systemic therapy.

Secondary Endpoint:

* Modified progression-free survival (mPFS) is defined as the survival interval without development of \>3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of \>6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis.
* Overall Survival
* Local control
* Toxicity
* HRQOL

Sample Size: 23 Patients will be enrolled.

Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

SAbR For Oligometastatic Renal Cell Carcinoma

Phase II Trial of SAbR for Patients With Oligometastatic Renal Cell Carcinoma

To evaluate the delay in time to start of systemic therapy (TTST) as a surrogate of progression free survival (PFS), defined as the time from the first day of SAbR to start of systemic therapy.

Modified progression-free survival (mPFS) for patients with oligometastatic renal cell carcinoma who are treated with SAbR. Modified progression-free survival (mPFS) is defined as the survival interval without development of \>3 sites of new metastasis, new sites of metastases that are not amenable to SAbR treatment, a total of \>6 sites of metastasis that required SAbR, local failure at SAbR-treated site, or development of brain metastasis, with the definition of new metastasis and local failure (progression) as defined by RECIST. "Metastasis" in this entire protocol refers to extra-cranial metastasis unless otherwise specified.

To evaluate progression on next line of systemic therapy as defined by RECIST 1.1 starting from mPFS (modified progression free survival). Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee \[Eur J Cancer. 2009;45(2):228-247\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.

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

Cancer specific survival is defined as the time between date of registration and the date of death due to renal cell carcinoma.

Radiographic progression with \>30% increase in the longest diameter of the treated lesions.

Median response duration is defined as the time between the date a response (CR or PR) was first seen until date of progression. Response and progression will be evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST v 1.1) Committee \[Eur J Cancer. 2009;45(2):228-247\]. Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST v1.1 criteria.

Interval time to development of new lesions that can be treated with additional local therapy- title would be this or a shortened version of it. Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

To measure the time interval from registration to time to disease progression that cannot be treated with further local therapy and need to initiate or switch systemic therapy. Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. Dose adjustments should be made according to the system showing the greatest degree of toxicity. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 occurring prior to 270 days from the start of protocol treatment. Other treatment related toxicity attributed to the therapy will be captured, recorded and the consequences of should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE). CTCAE V5.0 along with grades 1-5.

HRQOL will be measured using FACT-G questionnaire at baseline and at first follow up 8-12 weeks (+/- 4 weeks) then 12 week (±4 week) intervals for 1 year, and every 26 weeks (±4 weeks) until the completion of follow ups. FACT-G is a measure that sums the functional well being (FWB), physical well being (PWB), the social/family well-being (S/FWB), and emotional well being (EMB).

HRQOL will be measured using EQ-5D (EuroQol- 5 Dimension) questionnaire at baseline and at first follow up 8-12 weeks (+/- 4 weeks) then 12 week (±4 week) intervals for 1 year, and every 26 weeks (±4 weeks) until the completion of follow ups. EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

HRQOL will be measured using FKSI questionnaire at baseline and at first follow up 8-12 weeks (+/- 4 weeks) then 12 week (±4 week) intervals for 1 year, and every 26 weeks (±4 weeks) until the completion of follow ups. FKSI adds to the FACT-G (27 items) by including 15 items specific to kidney cancer patients. In a HRQOL study focused on patient with mRCC, a symptoms subscale questionnaire was developed and will also be administered in this study.

Health care utilization data needed to assess costs will be obtained from the cost \& convenience questionnaire, which includes costs of hospitalization, treatment, ER visits, physician and clinic visits and medications. Markov modeling with probabilistic sensitivity analysis will be used to correlate quality-adjusted survival and cost. Cost-effective analysis (cost \& convenience questionnaire) will be given prior to treatment and at the time of progression.

University of Texas Southwestern Medical Center

Associate Professor of Medicine

SAbR will be used to treat all sites of measurable metastases. New sites of metastasis will be treated if deemed appropriate by both medical and radiation oncologists with SAbR.

Metastatic kidney cancer patients on systemic therapy often develop resistance to limited sites that leads to changing of the systemic therapy. Local therapy to the sites of progression may allow patients to continue on the same systemic therapy that is otherwise effective and being tolerated well.

Hypothesis:

Stereotactic ablative radiation (SAbR) can delay the change of systemic therapy with oligoprogressive renal cell cancer (RCC) and improve progression free survival (PFS).

Primary Objectives:

• To evaluate the benefit of SAbR for oligo-progressive mRCC (Metastatic Renal Cell Cancer).

Secondary Objectives:

• To measure the toxicity, safety and tolerance of concurrent systemic therapy and SAbR for mRCC patients and its impact on quality of life.

The study is a prospective phase II, single arm, open label trial evaluating Stereotactic Ablative Radiation Therapy (SAbR) for patients with oligo-progressive RCC (Renal Cell Cancer).

Problem Statements:

* Can local therapy (SAbR) for oligoprogression delay the change of systemic therapy if progression is minimal to the progressive sites?
* Safely delaying the change of systemic therapy can have significant quality of life benefits for patients with oligo-progressive RCC.
* Can SAbR potentially improve progression free survival in oligoprogressive RCC patients?

Primary Endpoint:

• Time to change of systemic therapy.

Secondary Endpoint:

* PFS on subsequent systemic therapy (PFS-SST) after progression on SAbR.
* Overall survival(OS).
* Toxicity, safety and tolerance.
* Impact on health-related quality of life (HRQoL).

Sample Size: 20 Patients

Statistical Analysis: Time to event will be estimated using the Kaplan-Meier approach along with the 95% confidence interval.

SAbR For Oligo-Progressive Renal Cell Cancer.

A Phase II Trial of Stereotactic Ablative Radiation Therapy (SAbR) for Patients With Oligo-progressive Renal Cell Cancer (RCC).

SAbR for oligo-progression will be measured to delay the change of systemic therapy.

Progression-Free Survival on systemic therapy started (PFS-ST) after progression on SAbR with existing or new progression at \>3 or \>30% of all lesions.

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

Severity or Toxicity will be assessed according to the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE), version 5.0. The consequences of toxicity should all be graded 1-5 according to the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0.

HRQoL will be measured using Functional Assessment of Cancer Therapy (FACT-G)questionnaire. The FACT-G is a 28-item questionnaire that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.

HRQoL is measured using EuroQoL- 5 Dimension (EQ-5D) questionnaire. EQ-5D is a patient self-administrated questionnaire. The first part consists of 5 items covering 5 dimensions including: mobility, self care, usual activities, pain/discomfort, and anxiety/depression. Each dimension can be graded on 3 levels: 1-no problems, 2-moderate problems, and 3-extreme problems. Health states are defined by the combination of the leveled responses to the 5 dimensions, generating 243 health states to which unconsciousness and death are added. The 5-item index score is transformed into a utility score between. Possible scores range from 0-1, where higher score indicates better outcomes ( 0 ="Worst health state," and 1="Best health state." )

HRQoL will be measured using Kidney Symptom Index (FKSI) questionnaire. FKSI is a 15 question validated symptom index for kidney cancer patients that uses 5-point Likert-type response choices (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Possible scores range from 0-4, where higher scores indicate better outcome.

QOL will be measured using Cost \& Convenience Questionnaire. This outcome measure will not be used and data will not be collected or analyzed because of a protocol amendment Version 4 approved on 06/26/2020.

Radiographic progression with \>20% increase in the longest diameter of the treated lesions.

This outcome measure will not be used and data will not be collected or analyzed because this outcome measure was added in error at the time of the initial registration.

Principal Investigator

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

All Drugs and Chemicals

Pancrelipase

Pancreatin

50 Gy in five fractions SABR (once per day for 5 days) and use of the TTF system for 18 hours per day starting on the first day of SABR and continuing until abdominal disease progression

50 Gy in 5 fractions, once per day for 5 days

Stereotactic Ablative Body Radiation (SABR)

Participant will use the system for at least 18 hours per day starting on the first day of SABR until abdominal disease progression. Short treatment breaks are permitted for personal needs (such as to take a shower) and during radiation therapy. An additional treatment break is permitted for up to 48 hours every 21 days.

Tumor Treating Fields (TTF)

Michael Chuong, M.D.

Carolina Rojas

The purpose of this clinical trial is to determine whether using chemotherapy followed by stereotactic ablative body radiation therapy (SABR) and tumor treating fields (TTF) will slow tumor growth in people with locally advanced pancreas cancer. All participants will receive SABR therapy once per day for five days and use the TTF system for at least 18 hours per day starting on the first day of SABR until the tumor progresses or severe toxicity develops.

Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer

Phase 2 Trial of Ablative MRI-guided Stereotactic Body Radiation Therapy and Tumor Treating Fields for Locally Advanced Pancreas Cancer

PFS is defined as the time from the initiation of study therapy to the first documented disease progression or death due to any cause, whichever occurs first

LC is defined as a response within the radiation target volume according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).

LC is defined as a response within the radiation target volume according to RECIST) v1.1 criteria (i.e., percentage of participants with stable disease, partial response, or complete response).

DMFS is defined as the time from initiation of study therapy to the first radiographic confirmation of distant metastasis

OS is defined as the time from the initiation of study therapy to death due to any cause or date of last follow-up, whichever occurs first.

Quality of Life will be assessed using the Functional Assessment of Cancer Therapy - General (FACT-G), a 27-item questionnaire designed to measure four domains of QOL in cancer patients: physical, social, emotional, and functional well-being. Each domain has a scoring range of 0-28, for a combined total score of 0-108, where higher scores indicate better QOL.

All participants will be evaluable for toxicity from the time of their first treatment. All Grade 3+ toxicities \[according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0\] will be tracked, regardless of attribution to study treatment.

Location of recurrence is defined as the site(s) at the time of any first tumor recurrence: local only \[centroid of the recurrence within the planning target volume (PTV)\], distant only (centroid of the recurrence outside of the PTV), or local and distant.

The chemotherapy-free interval is defined as the duration of time from the initiation of study therapy to the date any chemotherapy is subsequently administered.

NovoCure Ltd.

Michael Chuong

Medical Director of Proton Therapy and Photon Therapy

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Squamous Cell

Lung Neoplasms

Neoplasms, Squamous Cell

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

11 Gy will be given in 5 fractions for a total dose of 55 Gy

12 Gy will be given in 5 fractions for a total dose of 60 Gy

13 Gy will be given in 5 fractions for a total dose of 65 Gy

14 Gy will be given in 5 fractions for a total dose of 70 Gy

The maximum tolerated radiation dose determined during Phase 1 (i.e. 11, 12, 13, or 14 Gy) will be given in 5 fractions for a total dose of 55, 60, 65, or 70 Gy.

Treatments shall not be delivered more frequently than every other day.

Tim Lautenschlaeger, MD

The purpose of this study is to test whether 5 fraction stereotactic ablative body radiation (SABR) is safe and improves local control for early state squamous cell carcinoma of the lung. While three fraction SABR is effective for the treatment of early stage non small cell lung carcinoma (NSCLC) of all histologies, it is not safe for many patients. While four and five fraction SABR is safe, recently published data and our institutional data suggests that local control for early stage squamous cell carcinoma of the lung using the current four or five fraction SABR is suboptimal.

1. Primary Objectives During Phase I study - Determine the safety and maximum tolerated radiation dose for five fraction SABR for squamous cell cancer of the lung.

   During Phase II study - Determine 2 year local control of dose escalated five fraction SABR vs. institutional historical control standard dose SABR in squamous cell cancer of the lung.
2. Phase II Secondary Objectives

   * Determine overall survival, progression free survival and patterns of failure after SABR.
   * Determine tolerability of dose escalated SABR.

This trial is a Phase I/II study designed to determine the maximum tolerated radiation dose and evaluate the efficacy of dose escalated SABR for early stage lung squamous cell carcinoma.

\*The Phase l portion of this study was completed. However; the trial will not continue into Phase II as originally planned.

Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Phase I/II Trial Evaluating Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung

Any event per CTCAE v.4 that occurs within 30 days from the start of SABR, and is possibly, probably or definitely related to treatment, and is related to a specific list of symptoms which are outlined in the protocol.

Failures will be classified as local failures if failing within or immediately adjacent to the PTV, unless judged by the investigator team to convincingly be a separate lesion from the treated lesion (i.e. new lesion within a planning target volume but across a fissure).

Length of time start of treatment that patients are still alive

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
SAbR For Oligometastatic Renal Cell Carcinoma	NCT02956798	Oligometastatic...	Stereotactic ab...	18 Years -	University of Texas Southwestern Medical Center
SAbR For Oligo-Progressive Renal Cell Cancer.	NCT03696277	Oligoprogressiv...	Stereotactic ab...	18 Years -	University of Texas Southwestern Medical Center
Stereotactic Body Radiation and Tumor Treating Fields for Locally Advanced Pancreas Cancer	NCT05679674	Pancreas Cancer Locally Advance... Locally Advance...	Stereotactic Ab... Tumor Treating ...	18 Years -	Baptist Health South Florida
Five Fraction SABR Dose Escalation for Early Stage Squamous Cell Carcinoma of the Lung	NCT03321747	Lung Cancer	Stereotactic Ab...	18 Years -	Indiana University

Spots Global Cancer Trial Database for stereotactic ablative body radiation (sabr)