Clinical trial NCT04553471: Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
Official title: A Trial of Palliative Lattice Stereotactic Body Radiotherapy (SBRT) for Patients With Sarcoma, Thoracic, Abdominal, and Pelvic Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Thoracic Cancer
Abdominal Cancer
Pelvic Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Goldman Sachs Foundation (Emerson Collective)
First posted: 2020-09-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: At least 10 participants will be enrolled in each cohort (soft tissue sarcomas, thoracic cancers, abdominal, and pelvic cancers).
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Rate of Local Control
timeFrame: At 6 months
measure: Number of Participants With Treatment-related, Non-hematologic Grade ≥ 3 Toxicity
timeFrame: Through 6 months
Secondary outcomes:
measure: Mean Change From Baseline - PROMIS Physical Function Assessment
timeFrame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Mean Change From Baseline-PROMIS Global Health Physical Assessment
timeFrame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Mean Change From Baseline-PROMIS Depression Assessment
timeFrame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Mean Change From Baseline-PROMIS Anxiety Assessment
timeFrame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Mean Change From Baseline-Numeric Pain Scale
timeFrame: 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Gastrointestinal Cancer Sites)
timeFrame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Pelvic Cancer Sites)
timeFrame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Sarcoma Cancer Sites)
timeFrame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
measure: Patient Reported Toxicity as Measured by PRO-CTCAE Assessment (Thoracic Cancer Sites)
timeFrame: Baseline, 2 weeks post-treatment (approximately week 4), 30 days, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pamela Samson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duriseti S, Kavanaugh J, Goddu S, Price A, Knutson N, Reynoso F, Michalski J, Mutic S, Robinson C, Spraker MB. Spatially fractionated stereotactic body radiation therapy (Lattice) for large tumors. Adv Radiat Oncol. 2021 Jan 8;6(3):100639. doi: 10.1016/j.adro.2020.100639. eCollection 2021 May-Jun.