NCT03575611

Stereotactic Body Radiation Therapy in Treating Patients With Oligometastatic Renal Cell Carcinoma

Suspended Phase 2 Last updated 15 April 2026

What this trial tests

Phase 2 trial testing Biopsy in Metastatic Renal Cell Carcinoma in 123 participants. Suspended.

Timeline

14 June 2018

Primary endpoint
20 August 2024

30 September 2030

Quick facts

Lead sponsor	M.D. Anderson Cancer Center
Phase	Phase 2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	123
Start date	14 June 2018
Primary completion	20 August 2024
Estimated completion	30 September 2030
Sites	1 location across United States

Drugs / interventions tested

• Biopsy — full drug profile →
• Biospecimen Collection — full drug profile →
• Computed Tomography
• Magnetic Resonance Imaging
• Positron Emission Tomography
• Stereotactic Body Radiation Therapy — full drug profile →

Conditions studied

• Metastatic Renal Cell Carcinoma — all drugs for Metastatic Renal Cell Carcinoma →
• Stage IV Renal Cell Cancer AJCC v8 — all drugs for Stage IV Renal Cell Cancer AJCC v8 →

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Metastatic Renal Cell Carcinoma or Stage IV Renal Cell Cancer AJCC v8. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase II trial studies how well stereotactic body radiation therapy works in treating patients with kidney cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Definitive radiotherapy in lieu of systemic therapy for oligometastatic renal cell carcinoma: a single-arm, single-centre, feasibility, phase 2 trial.
   Tang C, Msaouel P, Hara K, Choi H, et al · · 2021 · cited 126× · PMID 34717797 · DOI 10.1016/s1470-2045(21)00528-3
2. Review of Prognostic Expression Markers for Clear Cell Renal Cell Carcinoma.
   Petitprez F, Ayadi M, de Reyniès A, Fridman WH, et al · · 2021 · cited 30× · PMID 33996558 · DOI 10.3389/fonc.2021.643065
3. Beyond the Knife in Renal Cell Carcinoma: A Systematic Review-To Ablate or Not to Ablate?
   Green H, Taylor A, Khoo V. · · 2023 · cited 9× · PMID 37444565 · DOI 10.3390/cancers15133455
4. Focal therapy for oligometastatic and oligoprogressive renal cell carcinoma: a narrative review.
   Anderson AC, Ho J, Hall ET, Hannan R, et al · · 2024 · cited 4× · PMID 39258792 · DOI 10.1080/14796694.2024.2389769
5. Metastasis-directed radiotherapy without systemic therapy for oligometastatic clear-cell renal-cell carcinoma: primary efficacy analysis of a single-arm, single-centre, phase 2 trial.
   Tang C, Sherry AD, Seo A, Hara K, et al · · 2025 · cited 2× · PMID 40915303 · DOI 10.1016/s1470-2045(25)00380-8
6. Metastasis-directed Therapy With or Without Pembrolizumab for Oligometastatic Clear Cell Renal Cell Carcinoma: Pooled Analysis of Two Prospective Single-arm Phase 2 Trials.
   Sherry AD, To V, D'souza C, Kiany S, et al · · 2026 · PMID 42049596 · DOI 10.1016/j.eururo.2026.03.024
7. KIM-1 and Circulating Tumor DNA Are Prognostic Markers for Oligometastatic Clear-cell Renal Cell Carcinoma: Development of a Multivariable Prognostic Model.
   Tang C, Seo A, Sherry AD, Yang P, et al · · 2026 · PMID 41765697 · DOI 10.1016/j.eururo.2026.01.004
8. 7Phase 2 trial of metastasis directed radiotherapy without systemic therapy (MRWS) for oligometastatic clear cell renal cell carcinoma (ccRCC) and investigation of circulating tumor DNA (ctDNA)
   · 2025