Consolidative Radiation Therapy for the Treatment of Pediatric and Young Adult Patients with Metastatic or Progressive Soft Tissue or Bone Sarcoma, Target-RT Trial

Status: active

This clinical trial tests how well consolidative radiation therapy (cRT) works in treating pediatric and young adult patients with soft tissue or bone sarcoma that has spread from where it first started (primary site) to other places in the body (metastatic) or that is growing, spreading, or getting worse (progressive). Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill tumor cells and shrink tumors. Standard treatment usually involves treatment to the primary tumor and/or some of the sites of metastatic disease. Consolidative therapy is treatment that is given after initial therapy and is used to kill any tumor cells that may be left in the body. This study changes standard radiation treatment to cRT and delivers radiation therapy all sites of metastatic disease. Prior studies have shown that radiation to all sites of metastatic disease can decrease future disease progression and improve overall survival in other types of tumors. Giving cRT may kill more tumor cells and prevent the tumor from returning in pediatric and young adult patients with metastatic or progressive soft tissue or bone sarcoma.

Inclusion Criteria

STRATUM A: Patients must be aged =< 39 years at time of enrollment
STRATUM A: Patients must have a Karnofsky or Lansky performance score of 70 or greater or Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
STRATUM A: Patients must have newly diagnosed histologically or molecularly confirmed soft tissue or bone sarcoma at any site
STRATUM A: Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 3mm with CT scan within 3 weeks from treatment start
STRATUM B: Patients must have a Karnofsky or Lansky performance score of 70 or greater or ECOG performance status of 0-1
STRATUM B: Patients must have radiographic, histologic or molecular confirmation of progressive soft tissue or bone sarcoma at any site that was initially diagnosed at age =< 39 years. Progression includes progression at a new site or known sites of prior disease (e.g. recurrent)
STRATUM B: Patients must have metastatic disease that is measurable and this is defined as at least one lesion discontinuous from the primary that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 3mm with CT scan
STRATUM B: Radiation to at least one site is being recommended as part of second line therapy

Exclusion Criteria

STRATUM A: Brain or intracranial metastases, including leptomeningeal disease
STRATUM A: Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment
STRATUM A: Positive bone marrow biopsy for non-pelvic primary and greater than eight bone metastases. Presence of parenchymal lung metastases is considered as one metastasis, irrespective of how many lung nodules are present
STRATUM A: Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions
STRATUM A: Pregnancy
STRATUM B: Brain or intracranial metastases, including leptomeningeal disease
STRATUM B: Clinical or radiologic evidence of spinal cord compression requiring emergent radiation treatment
STRATUM B: Evidence of any non-measurable metastatic disease including but not limited to leptomeningeal disease, malignant ascites and malignant pleural or pericardial effusions
STRATUM B: Pregnancy

PRIMARY OBJECTIVE:

I. To determine the improvement in 2-year event free survival (EFS1) after cRT in patients with oligometastatic sarcoma as compared to historical control (applies to newly diagnosed [Stratum A] patients).

SECONDARY OBJECTIVES:

I. To determine the 2-year overall survival (OS) after cRT (applies to newly diagnosed [Stratum A] patients).

II. To determine differences in clinical outcomes after cRT between Ewing sarcoma (EWS), rhabdomyosarcoma (RMS) and other sarcoma histologies (applies to newly diagnosed [Stratum A] patients).

III. To determine time to next line systemic therapy (TtNT) after cRT (applies to newly diagnosed [Stratum A] patients).

IV. To determine the cumulative incidence of local failure of each treated site (applies to newly diagnosed [Stratum A] patients).

V. To describe toxicity after consolidative radiation using grading with Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 5.0 (applies to newly diagnosed [Stratum A] patients).

VI. To characterize use, local control and clinical outcomes (event free survival [EFS]2 and OS) of metastatic radiation or re-irradiation in patients who have undergone a first progression (applies to Stratum B).

EXPLORATORY OBJECTIVES:

I. To compare longitudinal plasma circulating tumor deoxyribonucleic acid (ctDNA) in patients who develop disease progression as compared to those who do not (applies to stratum A and B).

II. To compare clinical outcomes (EFS1, OS, local control) of cRT based on subgroups including age (< 18 years old [yo] versus 18-39 yo), number of metastatic lesions (1-2 versus 3 and greater), sites of metastases (lung and/or bone only versus other), and involvement of bone marrow at diagnosis (yes versus [vs] no) (applies to stratum A).

OUTLINE: Patients with newly diagnosed metastatic soft tissue or bone sarcoma are assigned to Stratum A. Patients with recurrent or progressive metastatic soft tissue or bone sarcoma are assigned to Stratum B.

STRATUM A: Patients receive standard of care induction chemotherapy. Patients with no disease progression then undergo radiation therapy (RT) or surgical resection to the primary site with stereotactic body radiation treatment (SBRT) to metastatic sites either at the same time as primary site RT or within 8 weeks of primary site RT completion. Patients with progression may optionally enroll on Stratum B if radiation is recommended. Additionally, patients undergo blood sample collection, magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET)/CT throughout the study.

STRATUM B: Patients undergo second line systemic therapy with RT to at least one site per standard of care. Additionally, patients undergo blood sample collection, MRI, CT and PET/CT throughout the study.

After completion of study treatment, patients are followed up every 3 months for up to 2 years, then every 6 months for 3 years.

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Consolidative Radiation Therapy for the Treatment of Pediatric and Young Adult Patients with Metastatic or Progressive Soft Tissue or Bone Sarcoma, Target-RT Trial

Inclusion Criteria

Exclusion Criteria

United States

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Baltimore

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Consolidative Radiation Therapy for the Treatment of Pediatric and Young Adult Patients with Metastatic or Progressive Soft Tissue or Bone Sarcoma, Target-RT Trial

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