NCT02581384

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2017

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 21, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
9 months until next milestone

Results Posted

Study results publicly available

April 30, 2021

Completed
Last Updated

April 30, 2021

Status Verified

April 1, 2021

Enrollment Period

3.6 years

First QC Date

October 19, 2015

Results QC Date

March 5, 2021

Last Update Submit

April 5, 2021

Conditions

Ewing SarcomaRhabdomyosarcomaWilms TumorOsteosarcomaNon-Rhabdomyosarcoma Soft Tissue Sarcoma, NosRenal TumorRhabdoid TumorClear Cell Renal Cell CarcinomaSarcomaSarcoma, EwingSoft Tissue Sarcoma

Keywords

Ewing SarcomaRhabdomyosarcomaWilms TumorRhabdomyosarcoma of MediastinumEwing's Sarcoma MetastaticEwing Family of TumorsEwing's Tumor MetastaticOsteosarcoma, MetastaticOsteosarcoma in ChildrenRhabdoid TumorLung MetastasisRadiation for ChildrenSBRT for childrenStereotactic Body RadiotherapyPulmonary MetastasisLung Metastasis in ChildrenPulmonary Metastasis in ChildrenComfort CarePalliative Care

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Dose Limiting Toxicity [Phase I]

    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.

    Up to 6 months

  • Overall Response Rate [Phase II]

    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.

    6 weeks

Secondary Outcomes (4)

  • Complete Response Rate [Phase II]

    6 weeks

  • 2 Year Local Control Rate [Phase II]

    24 Months

  • Percentage of Participants With 2-Year Failure-Free Survival [Phase II]

    24 months

  • Number of Participants With Grade 3 or Higher Adverse Events [Phase I and II]

    Up to 6 months post-treatment (6 months and 2 weeks)

Study Arms (6)

Cohort 1 Dose Level 1 [Phase I]

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 1 Dose Level 2 [Phase I]

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 1 Dose Level 3 [Phase I]

EXPERIMENTAL

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.

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase I]

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 3 [Phase I]

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiotherapy (SBRT)

Cohort 2 Dose Level 2 [Phase II]

EXPERIMENTAL

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

Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Stereotactic Body Radiotherapy (SBRT)RADIATION
Cohort 1 Dose Level 1 [Phase I]Cohort 1 Dose Level 2 [Phase I]Cohort 1 Dose Level 3 [Phase I]Cohort 2 Dose Level 2 [Phase II]Cohort 2 Dose Level 2 [Phase I]Cohort 2 Dose Level 3 [Phase I]

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of Ewing sarcoma, rhabdomyosarcoma, osteosarcoma, non-rhabdomyosarcoma soft tissue sarcoma, Wilms tumor or other primary renal tumor (including clear cell and rhabdoid)
  • Age ≤ 21 years;
  • Must be capable of treatment without general anesthesia
  • Lesion size 8 mm - 3 cm
  • Subjects who have lesions within 2 cm of central structures, will be eligible on a case by-case basis
  • Pulmonary metastases found at relapse (does not have to be first relapse); no more than 3 lesions per hemi-thorax will be treated but other lesions in the lung may be present
  • Greater than 5 weeks from doxorubicin at the time of consent, with radiation to be initiated no less than 6 weeks from doxorubicin
  • Informed consent/assent
  • Life expectancy \>3 months
  • Pulmonary Function FEV1 ≥ 50% of predicted;
  • Concurrent immunotherapy is allowed

You may not qualify if:

  • Lesion larger than 3 cm in diameter
  • Patients for whom surgery would be deemed appropriate rather than radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Liu KX, Chen YH, Kozono D, Mak RH, Boyle PJ, Janeway KA, Mullen EA, Marcus KJ. Phase I/II Study of Stereotactic Body Radiation Therapy for Pulmonary Metastases in Pediatric Patients. Adv Radiat Oncol. 2020 Sep 23;5(6):1267-1273. doi: 10.1016/j.adro.2020.09.004. eCollection 2020 Nov-Dec.

    PMID: 33305087RESULT

MeSH Terms

Conditions

Sarcoma, EwingRhabdomyosarcomaWilms TumorOsteosarcomaSarcomaCarcinoma, Renal CellRhabdoid TumorNeuroectodermal Tumors, Primitive, PeripheralNeoplasm Metastasis

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Neoplasms, Bone TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsMyosarcomaNeoplasms, Muscle TissueNeoplasms, Complex and MixedKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplastic Syndromes, HereditaryFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeuroectodermal Tumors, PrimitiveNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Limitations and Caveats

The study had small sample size / weak accrual.

Results Point of Contact

Title
Karen Marcus MD
Organization
Dana-Farber Cancer Institute
karen_marcus@dfci.harvard.edu
16177328783

Study Officials

  • Karen Marcus, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Karen J Marcus, M.D.

Study Record Dates

First Submitted

October 19, 2015

First Posted

October 21, 2015

Study Start

January 1, 2017

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

April 30, 2021

Results First Posted

April 30, 2021

Record last verified: 2021-04

Locations

US(3)