Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma Thoracic Abdominal and Pelvic Cancers

  • STATUS
    Recruiting
  • End date
    Jan 31, 2023
  • participants needed
    68
  • sponsor
    Washington University School of Medicine
Updated on 24 September 2021
cancer

Summary

This is a study evaluating the safety and efficacy of Lattice SBRT for patients with large tumors ( 4.5 cm) planning to undergo palliative radiotherapy.

Details
Condition Connective and Soft Tissue Neoplasm, Sarcoma, Pelvic Neoplasm, All Solid Tumors, Solid Tumors, Thoracic Cancer, Abdominal Cancer, Sarcoma (Pediatric), Pelvic Cancer, Soft Tissue Sarcoma, sarcomas, soft tissue sarcomas
Treatment Stereotactic body radiotherapy, Research blood draw
Clinical Study IdentifierNCT04553471
SponsorWashington University School of Medicine
Last Modified on24 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically or cytologically confirmed sarcoma (including extremity), thoracic cancer (including esophageal), abdominal cancer (including retroperitoneal sarcoma), or pelvic cancer
Planning to undergo palliative radiotherapy to a lesion 4.5 cm as measured with radiographic imaging or with calipers by clinical exam
ECOG performance status 2
At least 18 years of age
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

Exclusion Criteria

Prior high-dose radiotherapy that overlaps with any planned site of protocol radiotherapy. Patients where the Lattice SBRT fields may overlap with the low dose (<10 Gy) region of prior radiotherapy treatments are eligible and may be treated if this is determined to be safe by the treating physician
Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture
Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the Lattice SBRT administration
Cytotoxic chemotherapy and VEGF inhibitors prior to radiotherapy or planned after radiotherapy delivery are allowed at the discretion of the treating radiation oncologist. This includes continuing a treatment plan which was initiated prior to the start of radiotherapy. A 2-week washout is recommended, but not required
Pregnant. Women of childbearing potential must have a negative pregnancy test within 20 days of study entry
Patients with HIV are eligible unless their CD4+ T-cell counts are < 350 cells/mcL or they have a history of AIDS-defining opportunistic infection within the 12 months prior to registration. Concurrent treatment with effective ART according to DHHS treatment guidelines is recommended. Recommend exclusion of specific ART agents based on predicted drug-drug interactions (i.e. for sensitive CYP3A4 substrates, concurrent strong CYP3A4 inhibitors (ritonavir and cobicistat) or inducers (efavirenz) should be contraindicated)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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