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NCT Number: NCT05733156

Abscopal Effect from the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy

Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.

Recruiting

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who can provide their written informed consent
  • Age ≥19 years
  • Patients with histologically confirmed primary solid (irrespective of the status of the primary tumor)
  • Patients with ECOG performance status 0-2
  • Patients planning stereotactic body radiotherapy (three fractions) for extracranial metastases
  • Based on RECIST v1.1, patients with at least one extracranial measurable lesion other than SBRT lesions
  • Patients with one or more measurable lesions, which are not suitable for SBRT or palliative radiotherapy and can be considered for LDRT (bone metastasis is not indicated for LDRT)
  • Patients with hematologic function suitable for radiotherapy (absolute neutrophil count ≥1,500/mm^3, hemoglobin ≥9 g/dL, platelet count ≥100,000/mm^3)
  • Patients with a life expectancy of 6 months or more according to the researcher's judgment

Exclusion criteria

  • Patients participating in other clinical studies that may affect the efficacy/safety of this clinical study
  • Patients with brain metastasis
  • Patients planning SBRT for all measurable lesions due to oligometastasis
  • Patients with a history of radiotherapy for extracranial metastases within 3 months of the enrollment
  • Patients unable to cooperate with stereotactic body radiotherapy
  • Patients who are pregnant or planning to
  • Patients with advanced or multiple malignancies requiring aggressive treatment (excluding skin cancers other than melanoma or intraepithelial cancer)
  • Patients who have received systemic steroid therapy or immunosuppressive therapy within 2 weeks of enrollment - Patients with an (e.g. allergic disease, radiation pneumonitis, etc.) (The use of steroids for preventive purposes is allowed (e.g., to prevent vomiting during chemotherapy)) active autoimmune disease requiring systemic treatment within the past 2 years, evidence of clinically severe autoimmune disease, or syndrome requiring systemic steroid or immunosuppressive therapy (Patients who need intermittent use of bronchodilators, inhaled steroids, or topical steroid injections, hypothyroid patients on stable hormone replacement therapy, type 1 diabetes patients, or patients recovering from childhood asthma/atopic dermatitis are permitted)
  • Patients with active infection requiring systemic treatment

Treatment and study plan

SBRT + LDRT

Radiation

Stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT.

Primary outcomes

  1. Abscopal effect rate of low-dose radiotherapy lesions

    Time frame: 3 months after completion of radiotherapy

    The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1

Secondary outcomes

  1. Abscopal effect rate of low-dose radiotherapy lesions

    Time frame: 1, 6, and 12 months after completion of radiotherapy

    The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1

  2. Overall response rate

    Time frame: 1, 3, 6, and 12 months after completion of radiotherapy

    The proportion of patients showing complete or partial response of metastatic lesions

  3. Progression-free survival rate

    Time frame: 12 months after completion of radiotherapy

    From the date of enrollment to the date of progression or death assessed by RECIST v1.1

  4. Overall survival rate

    Time frame: 12 months after completion of radiotherapy

    From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1

  5. Adverse event

    Time frame: 12 months after completion of radiotherapy

    The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0

  6. Immune cell subsets of peripheral blood and tissue samples

    Time frame: 1 and 3 months after completion of radiotherapy

    Number of immune cell count

Study contacts

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

Jae Sik Kim, MD

CONTACT

[email protected]

+82-2-709-3254

Sponsors and collaborators

Lead sponsor

Soonchunhyang University Hospital

Other

Collaborators

  • Chungnam National University Hospital
  • SMG-SNU Boramae Medical Center
  • Saint Vincent's Hospital, Korea
  • Seoul National University Hospital
  • Soonchunhyang University Cheonan Hospital

Registry information

Official study title

Abscopal Effect from the Addition of Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy: a Multicenter, Single-arm Clinical Study (KROG 22-11)

Acronym: KROG22-11

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Feb 17, 2023
Registry last updated
Dec 10, 2024

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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