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NCT Number: NCT07413523

Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA

Bladder cancer is the most common type of urothelial cancer. When the disease has spread to other parts of the body (metastatic disease), the prognosis is often poor, because there are only a few effective treatment options available.

At the moment, standard treatment mainly includes systemic therapies, such as chemotherapy and immunotherapy (immune checkpoint inhibitors). These treatments act on the whole body. However, the use of local treatments, such as stereotactic radiotherapy, has not been well studied in bladder cancer.

Stereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions. This technique is already widely used to treat a limited number of metastases (called oligometastases) from other types of cancer.

The aim of this study is to understand whether stereotactic radiotherapy is also effective and safe for treating oligometastases coming from bladder cancer.

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Key information

Conditions

Bladder Cancer Carcinoma Carcinoma, Transitional Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Oligometastasis Urinary Bladder Diseases Urinary Bladder Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms Urothelial Carcinoma (UC)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • WHO performance status ≤ 2
  • Pathological proven urothelial carcinoma
  • Stage IV disease at imaging
  • Maximum of 3 extracranial metastases
  • Indication to receive I or II line of standard systemic therapy
  • Adequate liver function
  • Adequate bone marrow function
  • Written informed consent

Exclusion criteria

  • Inability to provide informed consent
  • Previous radiation therapy on the same target lesions
  • Pregnant or breastfeeding patients
  • Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
  • Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
  • WHO PS >=3

Treatment and study plan

SBRT

Radiation

Stereotactic radiotherapy is a type of radiation treatment that delivers very high doses of radiation to the tumor in a small number of treatment sessions, it wil be used to treat oligometastatic disease

Primary outcomes

  1. SBRT Outcome

    Time frame: From treatment to 12 months follow up

    evaluation of the effectiveness of treatment through conventional imaging. The response will be classified according to RECIST (Response Evaluation Criteria in Solid Tumours, version 1.1) and PERCIST13 criteria

Secondary outcomes

  1. SBRT Toxicities

    Time frame: From treatment to 12 months follow up

    assessment of treatment-related toxicities following the CTCAE V. 4.0 scale

  2. quality of life of treated patients

    Time frame: from treatment to 12 months follow up

    Quality of life will be scored using the Quality of life questionnaire (QLQ)-C30. a low score means a good quality of life while high values indicate a poor quality of life.

  3. immune response in patients treated with SBRT

    Time frame: from treatment to 12 months follow up

    Monitoring of the dynamics of innate (monocytic and granulocytic cells, Natural killer cells) and adaptive (T cells, B cells) immune subsets in the peripheral blood of patients before and after RT.

Study contacts

Contact information is provided by the study sponsor or research team.

Ciro Franzese, MD, Radiation oncologist

CONTACT

[email protected]

+39 0282247454

Marta Scorsetti, MD, Radiation oncologist

CONTACT

[email protected]

+39 0282248524

Sponsors and collaborators

Lead sponsor

Istituto Clinico Humanitas

Other

Collaborators

  • Varian, a Siemens Healthineers Company

Registry information

Official study title

Randomized Trial of stAndard of Care With or Without Metastases-directed Stereotactic Body Radiation Therapy in Patients Affected by Oligometastatic uRothelial carcinomA: ASTRA Trial

Acronym: ASTRA

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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