All > North Carolina > Milwaukee

Stereotactic Ablative Radiotherapy for Renal Cell Carcinoma

UNC Lineberger Comprehensive Cancer Center, Chapel Hill, NC
Renal Cell Carcinoma+3 More ConditionsStereotactic Ablative Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests whether adding radiation to standard immunotherapy improves outcomes for patients with metastatic renal cell cancer.

Eligible Conditions
  • Stage III Renal Cell Carcinoma
  • Unresectable Renal Cell Carcinoma
  • Stage IV Renal Cell Carcinoma
  • Kidney Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Similar Trials

1
Patients with metastatic or unresectable clear cell renal cell carcinoma
1
MEDI5752
1
bland embolization

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: From randomization to last follow-up, up to 8 years

Year 8
Nephrectomy and radiographic progression-free survival (nrPFS)
Nephrectomy and radiographic progression-free survival excluding nephrectomies that were performed for non-protocol specified reasons (nrPFS2)
Overall survival
Percentage of participants who undergo cytoreductive nephrectomy
Percentage of participants with complete or partial response
Percentage of participants with complete or partial response in the primary renal mass
Percentage of participants with grade 3+ and with grade 4+ treatment-related adverse events
Radiographic progression-free survival (rPFS)
Second-line therapy-free survival
Treatment-free survival

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Patients with metastatic or unresectable clear cell renal cell carcinoma
1
MEDI5752
1
bland embolization

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Arm I (standard of care immunotherapy)
1 of 2
Arm II (SABR, standard of care immunotherapy)
1 of 2

Active Control

Experimental Treatment

240 Total Participants · 2 Treatment Groups

Primary Treatment: Stereotactic Ablative Radiotherapy · No Placebo Group · Phase 2

Arm II (SABR, standard of care immunotherapy)Experimental Group · 8 Interventions: Pembrolizumab, Stereotactic Ablative Radiotherapy, Avelumab, Nivolumab, Axitinib, Cabozantinib, Lenvatinib, Ipilimumab · Intervention Types: Biological, Radiation, Biological, Biological, Drug, Drug, Drug, Biological
Arm I (standard of care immunotherapy)ActiveComparator Group · 7 Interventions: Pembrolizumab, Avelumab, Nivolumab, Axitinib, Cabozantinib, Lenvatinib, Ipilimumab · Intervention Types: Biological, Biological, Biological, Drug, Drug, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 3
~2200
Avelumab
2017
Completed Phase 3
~3100
Nivolumab
2014
Completed Phase 3
~4460
Axitinib
2019
Completed Phase 2
~4590
Cabozantinib
2013
Completed Phase 2
~1310
Lenvatinib
2005
Completed Phase 3
~3590
Ipilimumab
2014
Completed Phase 3
~3280

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from randomization to last follow-up, up to 8 years

Who is running the clinical trial?

NRG OncologyLead Sponsor
221 Previous Clinical Trials
94,920 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,272 Previous Clinical Trials
41,230,488 Total Patients Enrolled
William A HallPrincipal InvestigatorNRG Oncology

Eligibility Criteria

Age 18+ · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have had or currently have another type of cancer, but it will not affect the safety or effectiveness of the treatment being studied.
You are not willing to undergo immediate surgery to remove a kidney tumor.
References

Frequently Asked Questions

Are new participants being accepted into this research trial?

"According to the data on clinicaltrials.gov, this clinical trial is looking for subjects as we speak. The study was first posted on 6/30/2022 and updated just last week on 7/29/2022." - Anonymous Online Contributor

Unverified Answer

How many people fit the requirements to be in this clinical trial?

"That is correct. The clinicaltrial.gov website lists this trial as currently open and recruiting patients. This study was first posted on June 30th, 2022 and was last updated on July 29th, 2022. There are 5 different sites enrolling a total of 240 participants." - Anonymous Online Contributor

Unverified Answer

In how many different healthcare facilities is this research project being conducted presently?

"The trial is currently running at 5 locations, which include the Carle Cancer Institute in Mattoon, Carle Physician Group-Mattoon/Charleston in Danville, and Carle on Vermilion in Effingham." - Anonymous Online Contributor

Unverified Answer

Has Stereotactic Ablative Radiotherapy undergone regulatory approval by the FDA?

"There is only some data supporting the safety of Stereotactic Ablative Radiotherapy, as this treatment is still in Phase 2 clinical trials. This means that while there have been no reports of serious adverse effects, it is unclear whether or not the treatment is effective." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top