Lattice Stereotactic Body Radiation Therapy (Lattice SBRT) for Localized Unresectable or Metastatic Conventional Type Chondrosarcoma

NCT04098887 | Withdrawn DMC FDA Device

• 1 other identifier: 19-x296
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Unresectable (including metastatic) conventional chondrosarcoma requires high dose radiation for local control. Radiation Oncologists have traditionally used long radiation courses and concern for toxicity to surrounding organs at risk. Stereotactic body radiation therapy (SBRT) has the ability to deliver high doses of radiation in a manner that may improve clinical response but has size limitations. SBRT delivered with lattice radiotherapy (LRT) may safely dose escalate smaller portions of the tumor and also provide improved cancer control. This study is to evaluate the safety and initial efficacy of this treatment approach.

Conditions

Metastatic Chondrosarcoma

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment related grade 3 or higher non-hematologic adverse events

  -As scored by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5

  From start of treatment through 90 days post-treatment (approximately 3.5 months)

Study Arms (1)

Lattice stereotactic body radiation therapy

EXPERIMENTAL

Patients with up to 10 chondrosarcoma lesions will undergo radiotherapy to all sites of disease. For lesions less than 4.5 cm, traditional SBRT will be used. For sites 4.5 cm or greater, Lattice SBRT will be used. For Lattice SBRT, radiotherapy will be prescribed to 20 Gy in 5 fractions delivered every other day with a LATTICE simultaneous integrated boost (SIB) to 66.7 Gy in 5 fractions.

Radiation: Lattice stereotactic body radiation therapy

Interventions

Lattice stereotactic body radiation therapy RADIATION

For Lattice SBRT, the daily prescription dose will be 20 Gy to be delivered to the PTV\_2000 with a simultaneous integrated boost of 66.7 Gy to be delivered to the PTV\_6670 over 5 fractions (4 Gy and 13.2 Gy to the PTV\_2000 and PTV\_6670, respectively).

Also known as: Lattice SBRT

Lattice stereotactic body radiation therapy

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed conventional chondrosarcoma.
• At least one, large targetable lesion defined as: 1 lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 45 mm with radiographic imaging or with calipers by clinical exam.
• Deemed metastatic and/or unresectable by multidisciplinary review. Patients with prior resection with gross residual disease that are subsequently deemed ineligible for further resection are allowed.
• Patients that have had prior chemotherapy are allowed
• At least 14 years of age
• ECOG performance status ≤ 2
• Normal bone marrow and organ function as defined below:
• Leukocytes ≥ 3,000/mcL
• Absolute neutrophil count ≥ 1,500/mcl
• Platelets ≥ 100,000/mcl
• Radiotherapy is known to be teratogenic. For this reason women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of the study, and 6 months after completion of the study
• Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

You may not qualify if:

• Dedifferentiated chondrosarcoma and extra-skeletal myxoid chondrosarcoma are excluded.
• Patients with greater than 5 measurable metastatic lesions as determined by multidisciplinary review are excluded
• Prior radiotherapy that overlaps with any planned site of protocol radiotherapy.
• Currently receiving any systemic cancer therapy agents. Systemic therapy prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist.
• Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Chondrosarcoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Sarcoma

Study Officials

• Matthew Spraker, M.D., Ph.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2019
• First Posted: September 23, 2019
• Study Start: October 31, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share