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RecruitingNCT07540260COSTAR-002Updated Apr 20, 2026

CAIX PET/ CT Guided Radiation Therapy in CcRCC.

An interventional study of PETCT-guided radiation therapy in Radiation Therapy, Metastatic Renal Cancer and Recurrent Renal Cell Cancer, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Sponsored by Peking University First Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2025, registered Apr 2026).
  • Started Nov 2025; still recruiting 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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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Conditions studied

  • Radiation Therapy
  • Metastatic Renal Cancer
  • Recurrent Renal Cell Cancer

Keywords

  • SBRT
  • Metastatic Renal Cancer
  • Recurrent Renal Cell Cancer
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In context

Kidney Neoplasms

956 studies on the registry are indexed under Kidney Neoplasms; 210 are open to participants now.

This study's planned enrollment of 70 is above the median of 43 across 650 interventional studies indexed under Kidney Neoplasms.

Browse Kidney Neoplasms studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    mccRCC

    mccRCC

    Radiation: PETCT-guided radiation therapy

Interventions

  • RadiationPETCT-guided radiation therapy

    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.

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What researchers measure

Primary outcomes

  1. PFS

    time from the start of treatment to progression

    Time frame: 2 year

Secondary outcomes

  1. local control rate

    local control rate of all irradiated lesions

    Time frame: 2 year

  2. Duration of current-line systemic therap

    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.

    Time frame: From first radiotherapy to change of systemic therapy due to disease progression (up to 3 years).

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Study locations

1 of 1 sites recruiting
  • Peking University First Hospital
    Beijing, Beijing Municipality 100034, China
    Recruiting
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References and documents

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. PubMed 23108238 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07540260
Lead sponsor
Peking University First Hospital
Responsible party
Sponsor
First posted
Apr 20, 2026
Start date
Nov 1, 2025
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Apr 20, 2026

Study contacts

Mingwei Ma
Contact
drmingweima@bjmu.edu.cn
+86-13693556512

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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