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Recruiting INTERVENTIONAL NCT04068649

Single-Fraction SBRT Versus Standard Palliative Radiation Therapy in Treating Patients With Metastatic Cancer

A Phase 2 Randomized Study With a Non-randomized Cohort : Assessing Single-Fraction SBRT Versus Standard Palliative Radiation in Patients With Metastatic Disease (ASTEROID)

Sponsor: Roswell Park Cancer Institute

Conditions Metastatic Malignant Neoplasm
Interventions Palliative Radiation Therapy Quality-of-Life Assessment Questionnaire Administration Stereotactic Body Radiation Therapy
Updated 14 times since 2019 Last updated: Apr 24, 2026 Started: Nov 18, 2019 Primary completion: Nov 18, 2027 Completion: Nov 18, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Metastatic Malignant Neoplasm, this trial is actively recruiting participants. The trial is conducted by Roswell Park Cancer Institute and has accumulated 14 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Study Description(click to expand)

PRIMARY OBJECTIVES: I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease. SECONDARY OBJECTIVES: I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy. EXPLORATORY OBJECTIVES: I. Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer. IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes. V. Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician. ARM II: Patients undergo single fraction SBRT. After completion of study treatment, patients may be followed up at 5 and 12 weeks.

PRIMARY OBJECTIVES:

I. To assess patient-reported pain response and quality of life (QoL) in patients randomized to either single-fraction stereotactic body radiation therapy (SBRT) or non-SBRT palliative radiation therapy for metastatic disease.

SECONDARY OBJECTIVES:

I. Compare overall survival for patients undergoing single fraction SBRT versus non-SBRT palliative radiation therapy.

EXPLORATORY OBJECTIVES:

I. Assess for changes in immune markers. II. Assess toxicity related to radiation treatment. III. Assess change in frailty index and cognitive function over time in patients undergoing treatment for metastatic cancer.

IV. Evaluate the effect of circadian rhythm and radiation treatment time on outcomes.

V. Assess the utility of the Pain Catastrophizing Index in patients undergoing radiation treatment for metastatic cancer.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative radiation therapy (RT) deemed appropriate by the treating physician.

ARM II: Patients undergo single fraction SBRT.

After completion of study treatment, patients may be followed up at 5 and 12 weeks.

Status Flow

~Sep 2019 – ~Oct 2019 · 30 days · monthly snapshot~Oct 2019 – ~Dec 2019 · 2 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Aug 2020 · 6 months · monthly snapshot~Aug 2020 – ~Jan 2021 · 5 months · monthly snapshot~Jan 2021 – ~Sep 2021 · 8 months · monthly snapshot~Sep 2021 – ~Jun 2022 · 9 months · monthly snapshot~Jun 2022 – ~Jun 2023 · 12 months · monthly snapshot~Jun 2023 – ~May 2024 · 11 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~May 2025 · 8 months · monthly snapshot~May 2025 – ~May 2026 · 12 months · monthly snapshotMay 4, 2026 – present · 3 months · daily API

Change History

14 versions recorded

  1. May 4, 2026 — Present [daily]

    Recruiting

    Phase: PHASE2 → None

  2. May 2025 — May 2026 [monthly]

    Recruiting PHASE2

  3. Sep 2024 — May 2025 [monthly]

    Recruiting PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

  5. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE2

▶ Show 9 earlier versions

  1. Jun 2023 — May 2024 [monthly]

    Recruiting PHASE2

  2. Jun 2022 — Jun 2023 [monthly]

    Recruiting PHASE2

  3. Sep 2021 — Jun 2022 [monthly]

    Recruiting PHASE2

  4. Jan 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  5. Aug 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  6. Feb 2020 — Aug 2020 [monthly]

    Recruiting PHASE2

    Phase: PHASE3 → PHASE2

  7. Dec 2019 — Feb 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet Recruiting → Recruiting · Phase: PHASE2 → PHASE3

  8. Oct 2019 — Dec 2019 [monthly]

    Not Yet Recruiting PHASE2

  9. Sep 2019 — Oct 2019 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with 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 can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Contact Information

Sponsor contact:
  • Roswell Park Cancer Institute
Data source: ClinicalTrials.gov

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations