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Radiation Therapy

Stereotactic Body Radiation Therapy for Kidney Cancer

N/A
Waitlist Available
Led By Chad Tang
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be greater than or equal to 18 years of age on the day of signing informed consent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 12 months
Awards & highlights

Study Summary

This trial studies how well stereotactic body radiation therapy works in treating patients with kidney cancer that has spread to other places in the body.

Who is the study for?
This trial is for adults with kidney cancer that has spread to up to 5 other body parts. They must be able to undergo biopsies, have a confirmed diagnosis of RCC, and meet certain health criteria like adequate blood cell counts and liver function. Pregnant women or those planning pregnancy are excluded, as well as patients with psychiatric issues affecting cooperation, widespread metastasis not treatable by the therapy, more than one line of systemic therapy for metastatic disease (except in specific cases), active rheumatologic diseases, or significant effusions.Check my eligibility
What is being tested?
The trial tests Stereotactic Body Radiation Therapy (SBRT) on patients with oligometastatic renal cell carcinoma (RCC). SBRT is a precise radiation treatment aimed at destroying tumor cells across fewer sessions while minimizing damage to surrounding healthy tissue.See study design
What are the potential side effects?
While the information provided does not specify side effects of SBRT, generally they can include fatigue, skin reactions at the treatment site such as redness or irritation, temporary swelling or pain around treated areas and potential damage to nearby organs depending on where tumors are located.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am able to get out of my bed or chair and move around.
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My kidney cancer has spread to 5 or fewer places.
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My kidney cancer diagnosis has been confirmed by a lab test.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Stereotactic body radiation therapy (SBRT) into a treatment plan
Secondary outcome measures
Freedom from new lesion development
Overall survival
Reduction in cellular replication as measured by ki-67 staining
+2 more

Side effects data

From 2022 Phase 2 trial • 29 Patients • NCT02045446
79%
Cough
64%
Dyspnea
64%
Nausea
57%
Fatigue
43%
Constipation
36%
Pain
36%
Dizziness
29%
Anemia
29%
Back pain
29%
Vomiting
21%
Anorexia
21%
Chest pain
21%
Lymphocyte count decreased
21%
Death NOS
21%
Anxiety
21%
Fall
14%
Wheezing
14%
Dysphagia
14%
Hypotension
14%
Depression
14%
Diarrhea
14%
Platelet count decreased
14%
Abdominal Pain
14%
Edema
14%
Fever
14%
Headache
14%
Insomnia
14%
Palpitations
7%
Alopecia
7%
Dehydration
7%
Blurred vision
7%
Sinusitis
7%
Otitis externa
7%
Dysgeusia
7%
Hemorrhoids
7%
Amnesia
7%
Confusion
7%
Hypertension
7%
Creatinine increased
7%
Dementia
7%
Productive cough
7%
Pneumonitis
7%
Dysuria
7%
White blood cell count decreased
7%
Throat pain
7%
Bone marrow biopsy
7%
Hearing impaired
7%
Rash
7%
Hypernatremia
7%
Eye pain
7%
Tachycardia
7%
Lung infection
7%
Neuropathy
7%
Pleuritic pain
7%
Neutropenia
7%
Hypoxia
7%
Aspiration pneumonia
7%
Blood bilirubin increased
7%
Muscle weakness
7%
Tremor
7%
Weight loss
7%
Thrombocytopenia
7%
Floaters
7%
Toothache
7%
Esophagitis
7%
Leukocytosis
7%
Edema limbs
7%
Gait disturbance
7%
Parathesia (tingling)
7%
Edema face
7%
COPD
100%
80%
60%
40%
20%
0%
Study treatment Arm
Stereotactic Body Radiation Therapy
Maintenance Chemotherapy

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (SBRT)Experimental Treatment1 Intervention
Patients undergo SBRT over 1 day to 3 weeks based on the judgment of the treating radiation oncologist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Cancer Prevention Research Institute of TexasOTHER
50 Previous Clinical Trials
98,408 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,123 Total Patients Enrolled
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,751 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
The Lancet OncologyJournal
Definitive Radiotherapy in Lieu of Systemic Therapy for Oligometastatic Renal Cell Carcinoma: A Single-arm, Single-centre, Feasibility, Phase 2 Trial
Tang, Chad, Pavlos Msaouel, Kieko Hara, Haesun Choi, Venus Le, Amishi Y Shah, Jennifer Wang, et al.. 2021. “Definitive Radiotherapy in Lieu of Systemic Therapy for Oligometastatic Renal Cell Carcinoma: A Single-arm, Single-centre, Feasibility, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00528-3.
The Lancet OncologyJournal
Definitive Radiotherapy in Lieu of Systemic Therapy for Oligometastatic Renal Cell Carcinoma: A Single-arm, Single-centre, Feasibility, Phase 2 Trial
Tang, Chad, Pavlos Msaouel, Kieko Hara, Haesun Choi, Venus Le, Amishi Y Shah, Jennifer Wang, et al.. 2021. “Definitive Radiotherapy in Lieu of Systemic Therapy for Oligometastatic Renal Cell Carcinoma: A Single-arm, Single-centre, Feasibility, Phase 2 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(21)00528-3.
clinicaltrials.govStudy
Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma
2018. "Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03575611.
All > Metastatic Renal Cell Carcinoma > Renal Cell Carcinoma
~6 spots leftby Sep 2025
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