Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplastic Processes

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

In the control group, stereotactic body radiotherapy (SBRT) alone is performed. SBRT is administered three times, at intervals of 1-2 days. The scattered dose should not exceed EQD2 2Gy to the non-irradiated lesion.

SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.

The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.

LDRT is planned to irradiate EQD2 (α/β=10) 6 Gy to lesions, considering the scattered dose caused by SBRT.

If there are non-irradiated lesions, they are defined as internal control, and the total dose is limited to 0.5 Gy or less.

CTV allows up to 5 mm margin for GTV, and 3-10mm for PTV margin from CTV. It is planned that the iso-dose line corresponding to the prescribed dose contains at least 90% of PTV and 95% of GTV.

SBRT + LDRT

SBRT is performed according to the protocol of each institution. However, the total fraction of SBRT is fixed to 3, and the treatment interval is maintained for 1-2 days.

The scattered dose should not exceed EQD2 (α/β=10) 2 Gy for non-irradiated lesions.

SBRT alone

Jae Sik Kim, MD

Ah Ram Chang, MD, PhD

Stereotactic body radiotherapy (SBRT) has been known to enhance the abscopal effect by up to 40% when delivered with immune checkpoint inhibitors (ICIs). Recently, preclinical and clinical studies demonstrate that metastatic lesions treated with non-cytotoxic low-dose radiotherapy (LDRT) significantly were reduced in the condition where SBRT and ICIs were administered together. Given that ICIs are highly expensive and some tumors are beyond the indications of ICIs, novel approaches are required to boost the abscopal effect in the absence of ICIs. Therefore, the investigators design a multicenter, randomized clinical trial that investigates the efficacy and safety of LDRT combined with SBRT in metastatic cancer patients. The primary endpoint is a lesion-specific response of LDRT lesions (i.e., abscopal effect) evaluated three months after radiotherapy.

Subjects will be randomly allocated into two groups (1:1) with the stratification by planning target volume and previous use of ICIs: control group (SBRT in three fractions) or experimental group (SBRT + LDRT in three factions). Unless patients agree with randomization, subjects will participate in a prospective cohort study.

Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy

Abscopal Effect From the Addition of Low-dose Radiotherapy in Metastatic Cancer Patients Receiving Stereotactic Body Radiotherapy: a Multicenter, Randomized Clinical Study

SMG-SNU Boramae Medical Center

Soonchunhyang University Hospital

Director of Radiation Oncology

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.

Byoung Hyuck Kim, MD, PhD

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.

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

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)

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

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

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

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Abscopal Effect From Low-dose Radiotherapy in Metastatic Cancer Combined With Stereotactic Body Radiotherapy	NCT05578274	Neoplasms Secondary Malig...	SBRT + LDRT SBRT alone	19 Years -	Soonchunhyang University Hospital
Abscopal Effect From the Low-dose Radiotherapy in Polymetastatic Cancer Patients Receiving Stereotactic Radiotherapy	NCT05733156	Neoplasms Secondary Malig...	SBRT + LDRT	19 Years -	Soonchunhyang University Hospital

Spots Global Cancer Trial Database for sbrt + ldrt

Every month we try and update this database with for sbrt + ldrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sbrt + ldrt

Every month we try and update this database with for sbrt + ldrt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sbrt + ldrt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.