Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Neoplasm Metastasis

Carcinoma, Renal Cell

Sarcoma

Osteosarcoma

Wilms Tumor

Sarcoma, Ewing

Neuroectodermal Tumors, Primitive, Peripheral

Kidney Neoplasms

Rhabdomyosarcoma

Rhabdoid Tumor

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplastic Processes

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Neoplasms, Bone Tissue

Neoplasms, Connective Tissue

Myosarcoma

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Neoplasms, Neuroepithelial

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Soft Tissue Sarcoma

Wilms' Tumor

Ewing Sarcoma

Neuroepithelioma

Participants with Wilms tumors or other primary renal tumors. Stereotactic Body Radiotherapy (SBRT) Dose Levels for each target lesion are three 8 Gy fractions for 24 Gy total.

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Participants with Wilms tumors or other primary renal tumors. SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Participants with Ewing sarcoma or rhabdomyosarcoma.SBRT Dose Levels for each target lesion are three 12 Gy fractions for 36 Gy total.

Stereotactic Body Radiotherapy (SBRT)

Karen Marcus, MD

This research study is studying stereotactic body radiotherapy (SBRT) as a possible treatment for lung relapse of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). SBRT is a form of targeted radiotherapy that can treat very small tumors using a few large doses.

This research study is a Pilot Study, also known as a Phase I-II study, which means it is the first time investigators are examining this study intervention for patients with lung recurrence of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, nonrhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid). This study tests the most appropriate dose, safety and efficacy of SBRT for the treatment of lung recurrence of these cancers in children. Standard radiotherapy is typically used to treat Ewing sarcoma and is used to treat lung recurrence. SBRT is being used to treat adults with small inoperable lung cancers; in such cases, SBRT has been shown to be effective and well-tolerated. SBRT is also used to treat bone metastases in adults and children.

Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Dose Limiting Toxicities (DLT's) are toxicities experienced from start of therapy to 6 month. DLT's are assessed on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.

DLTs are defined as follows:

Grade 2 or higher toxicities:

* Myelitis
* Esophageal fistula, perforation, hemorrhage

Grade 3 or higher toxicities considered to be a direct result of therapy:

* Pneumonitis
* Pericarditis, pericardial effusion
* Esophageal necrosis, stenosis, ulcer
* Dyspnea

Grade 4 toxicities:

* Esophagitis
* Pericardial tamponade
* Pulmonary toxicity excluding infectious pneumonia
* Skin toxicity
* Hemoptysis/pulmonary hemorrhage

Grade 5 toxicities, including:

* Pulmonary toxicity including pneumonitis
* Excluding infectious pneumonia

Three participants will enter the study in each cohort. If 0/3 patients experiences a DLT, this dose level will move forward to the Phase II and more participants will be enrolled.

Percentage of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) and Partial Response (PR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter.

Percentage of pulmonary lesions of participants with response after 6 weeks. Response on treatment was considered to be Complete Response (CR) measured according Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For target lesions, CR is complete disappearance of all target lesions.

Rate of local control (LC) of the index lesion after lung SBRT at 2 years. LC is defined as the absence of tumor progression within 1 cm of the primary tumor site. LC is measured by established methods.

Rate of distant lung failure-free survival defined lung failure or death from any cause at two years. Lung failure defined using established methods.

Grade 3 or higher adverse events as defined by controlled terminology criteria for adverse events (CTCAE) version 4.

Dana-Farber Cancer Institute

Karen J Marcus, M.D.

Serious Adverse Events (SAE's) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Participants with Ewing sarcoma or rhabdomyosarcoma. SBRT Dose Levels for each target lesion are three 10 Gy fractions for 30 Gy total.

Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase I]

Cohort 2 Dose Level 2 [Phase II]

Cohort 2 Dose Level 2 [Phase I and II]

Age, Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Primary Tumor Histologies

Number of Lesions

The study had small sample size / weak accrual.

Karen Marcus MD

Number of Participants With Dose Limiting Toxicity [Phase I]

It is pre-specified in the protocol that Phase I and Phase II populations for each cohort are combined for this analysis

Spots Global Cancer Trial Database for Stereotactic Body Radiotherapy (SBRT) for Pulmonary Metastases in Ewing Sarcoma, Rhabdomyosarcoma, and Wilms Tumors

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial