CAIX PET/ CT Guided Radiation Therapy in CcRCC.

NCT07540260 — Not applicable, Recruiting, 70 participants, Peking University First Hospital

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Registry	NCT07540260, acronym COSTAR-002
Status	Recruiting
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	70 (Estimated)
Sponsor	Peking University First Hospital (Other)
Conditions	Radiation Therapy, Metastatic Renal Cancer, Recurrent Renal Cell Cancer
Interventions	PETCT-guided radiation therapy (Radiation)
Dates	start 2025-11-01, primary completion 2030-12-31 (estimated), completion 2030-12-31 (estimated), first posted 2026-04-20, last updated 2026-04-20
Locations	1 site in China

-Summary

This is a prospective, single-arm study in adults with recurrent or metastatic clear cell renal cell carcinoma (ccRCC). Participants will receive standard systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) and undergo dual PET/CT imaging (FDG PET/CT and a CAIX-targeted PET/CT) to map disease sites. When feasible, PET/CT-visible lesions will be treated with image-guided stereotactic ablative radiotherapy (SABR). Patients will be followed to evaluate progression-free survival, local control of treated lesions, and treatment-related adverse events (planned enrollment: \~70).

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+Arms and interventions

Arm	Type	Interventions	Description
mccRCC	Experimental	Radiation: PETCT-guided radiation therapy	mccRCC

PETCT-guided radiation therapy (Radiation): PETCT-guided radiation therapy: All patients will undergo both FDG PET/CT and CAIX PET/CT. Radiotherapy will be planned and delivered based on the imaging findings, with the goal of achieving the most comprehensive feasible (all-site) coverage whenever appropriate.

+Outcome measures

Primary outcomes

PFS [2 year]: time from the start of treatment to progression

Secondary outcomes

local control rate [2 year]: local control rate of all irradiated lesions
Duration of current-line systemic therap [From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).]: Time (months) from the start date of the first radiotherapy course to the date when the current-line systemic therapy regimen must be changed due to disease progression. Oligoprogression managed with radiotherapy without changing systemic therapy will not be counted as an event.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

Adults (≥18 years) Histologically confirmed clear cell renal cell carcinoma Recurrent or metastatic disease Planned or ongoing first-line systemic therapy (targeted therapy plus anti-PD-1 immunotherapy) Dual PET/CT imaging available (FDG PET/CT and CAIX-targeted PET/CT) and eligible for radiotherapy planning Multidisciplinary assessment confirms radiotherapy is feasible to treat ≥75% of detectable lesions Able to provide written informed consent

Exclusion Criteria:

Unable to receive stereotactic radiotherapy as planned Uncontrolled serious comorbidities or active infection Pregnant or breastfeeding Unable or unwilling to comply with study procedures and follow-up

+Locations (1)

Facility	City	Country	Status
Peking University First Hospital	Beijing, Beijing Municipality	China	Recruiting

+Publications

Wang HY, Ding HJ, Chen JH, Chao CH, Lu YY, Lin WY, Kao CH. Meta-analysis of the diagnostic performance of [18F]FDG-PET and PET/CT in renal cell carcinoma. Cancer Imaging. 2012 Oct 26;12(3):464-74. doi: 10.1102/1470-7330.2012.0042. PMID 23108238

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