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SarcomaNCT01763970

Stereotactic Radiation Therapy for Pediatric Sarcomas

A study testing SBRT in people with Sarcoma and Metastatic Disease, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The stereotactic body radiation therapy (SBRT) literature focuses on clinical outcomes in the adult population. However, SBRT has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are… Read more about this study

Who is it for?
Ages 4 to 40 years
Conditions the study is for
Sarcoma, Metastatic Disease, Bony Sites
What is being tested?
SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
5 sitesUnited States
Study dates
Nov 2013to Apr 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 40 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • histologically or cytologically confirmed metastatic sarcoma of the soft tissue or bone
  • must have measurable disease
  • disease must be surgically unresectable as determined by a tumor board or surgeon
  • greater than 3 years of age
  • less than or equal to 40 years of age
  • life expectancy of at least 9 months
  • adequate performance status (Lansky Performance Status greater than or equal to 50).
  • ability to understand and willingness to sign informed consent document

Who cannot join

  • patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study
  • patients who have had any prior radiotherapy to the treatment site(s)
  • patients may not participate on any other treatment protocol while they are receiving treatment on this protocol and for up to 3 months after these protocol treatments have ended
  • pregnant women
  • refusal of women of child bearing potential to take a pregnancy test prior to treatment

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    Baltimore, Maryland, 21231

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105-3678

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Stanford Medical Center

    Stanford, California, 94305-5847

  • Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

Other trials in United States

About this study

Official title: A Phase II Study of Hyperfractionated Stereotactic Radiotherapy in the Treatment of Metastatic Pediatric Sarcomas of Bony Sites

The stereotactic body radiation therapy (SBRT) literature focuses on clinical outcomes in the adult population. However, SBRT has a particularly strong rationale for application in pediatrics given that high biologically effective doses have been shown to increase control in histologies, such as sarcoma, which are common in the pediatrics population. With stereotactic radiation therapy techniques, a reduction in normal tissue dose surrounding the target lesion of interest may also be accomplished resulting in lower toxicity. Given that pediatric patients with sarcomas, presenting with limited metastases in lung and bone, are still considered to be a curable population with aggressive local therapy, SBRT could have a significant impact on outcomes in oligometastatic patients who may be otherwise unresectable.

Read the detailed description

Pediatric patients with sarcoma who have limited metastases are still potentially curable with aggressive local therapy. However, conventional moderate dose radiation is unlikely to provide durable local control. Given the recent technologic advances in radiation delivery, it is now possible to deliver tumoricidal doses, using stereotactic radiation over a short time course with highly focal techniques. Stereotactic radiation has proven efficacious in the intracranial setting and in multiple extracranial sites in adults. It has not yet been well studied in the pediatrics population where there is a particularly strong rationale due to the ablative doses that can be delivered to tumor while simultaneously reducing high dose to normal tissues. The proposed trial is a single arm phase II study to determine the efficacy of SBRT in pediatric sarcomas with surgically unresectable metastatic disease. Oligometastatic sites eligible for treatment in this study include bony sites of disease. SBRT will be delivered to each eligible site to a total dose of 4000 delivered in 5 fractions of 800 per fractions each day. Following completion of SBRT, patients will undergo treatment response assessment with the use of diagnostic imaging, clinical examination, and completion of the Brief Pain Inventory to assess quality of life. The primary objective of this study is to determine the efficacy of SBRT delivered to a dose of 4000 centigray (cGy) in 5 fractions of 800 cGy each for patients greater than 3 years of age and < 40 years of age with metastatic disease of bone secondary to pediatric sarcoma. The secondary objectives of this study include describing the toxicity of SBRT with this regimen; assessing clinical response rate of each target lesion; assessing long-term clinical outcomes; and assessing quality of life following completion of treatment. For patients with potentially curable oligometastatic disease, surgical resection in conjunction with systemic therapy remains the standard of care. Patients on this study will continue to receive chemotherapy outside of the 2 week window for SBRT. Issues that may limit participation include our inability to assess late effects that may not develop till at least 10 years after therapy. For this reason, we will limit the population in this study to patients who are surgically unresectable and would be otherwise incurable with current standard systemic therapies.

Being tested
SBRT
Keywords
Stereotactic, Radiotherapy, Hypofractionated
Medical subject headings
Sarcoma, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SBRTRadiation

    Also called Stereotactic Body Radiation Therapy (SBRT)

Study groups in NCT01763970
Study groupRoleWhat they receive
Hypofractionated SBRTExperimental800 cGy delivered in 5 fractions every day to total dose of 4000 cGy
Receives: Radiation: SBRT

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled

    Local control was defined as the absence of local progression. Local progression was defined as:

    • (1) the development of a new soft tissue mass ≥1 cm at a site without a soft tissue component or with a soft tissue component <1 cm in at baseline
    • (2) an increase in the largest axial dimension of the soft tissue component by >20% in lesions with a ≥ 1 cm in soft tissue component at baseline
    • (3) a previous bone metastasis that was avid on fluorodeoxyglucose (FDG)-positron emission tomography (PET), became non-avid after SBRT, and then became avid again.

    The Kaplan-Meier method was used.

    Measured: 6 months post-SBRT

Secondary outcomes (5)

  1. Patient-specific Local Control at 6 Months Post-SBRT as Assessed by the Percentage of Patients Locally Controlled

    Patient-specific local control was calculated using the Kaplan-Meier method from initiation of SBRT to time of local failure. Patients who did not experience local failure were censored at the time of last follow up.

    Measured: 6 months post-SBRT

  2. Percentage of Patients With Progression-free Survival at 6 Months Post-SBRT

    To assess long-term clinical outcomes of this patient population after completion of SBRT by measuring progression-free survival. The Kaplan-Meier method was used to determine progression-free for survival from initiation of SBRT to progression (local or distant) or death due to any cause. Patients that did not have evidence of progression or who did not die, where censored at the time of last follow up.

    Measured: 6 months post-SBRT

  3. Percentage of Patients With Overall Survival at 6 Months Post-SBRT

    The Kaplan-Meier method was used to calculate overall survival from initiation of SBRT to death due to any cause. Patients who had not died at the time of the analysis were censored at the time of last follow up.

    Measured: 6 months post-SBRT

  4. Change in Quality of Life (QoL) as Assessed by the Brief Pain Inventory

    Quality of life was assessed using the Brief Pain Inventory (BPI) form which assesses the severity of pain and impact on functioning on an 11-point scale at each follow up visit. Paired sample Wilcoxon signed-rank tests were performed to assess changes in pain scores on the Brief Pain Inventory; 0 being no pain and 10 being the worst pain.

    Measured: Baseline and one-month post-SBRT

  5. Number of Participants Experiencing Toxicity of SBRT

    To describe the toxicity of SBRT delivered to study patients measured by the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

    Measured: 12 months after treatment starts

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2013 (estimated)
  2. Study startNov 2013
  3. Primary completion24 Sep 2018
  4. Study completionApr 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763970
Sponsor's protocol ID
J1367
Other IDs
NA_00070109
Status last verified
Aug 2020
First submitted
7 Jan 2013
Last updated
27 Aug 2020
Data monitoring committee
Yes
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing SBRT in people with Sarcoma and Metastatic Disease, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lesion-specific Local Control at 6 Months Post-SBRT as Assessed by Percentage of Lesions Locally Controlled (time frame: 6 months post-SBRT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01763970.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.

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