Palliative Spatially Fractionated (GRID) Radiotherapy Using Intensity Modulated Proton Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
Spatially fractionated radiotherapy (SFRT or GRID) addresses some limitations of traditional stereotactic body radiation therapy by relying on beam collimation to create high-dose "peaks" and intervening low-dose "valleys" throughout the target volume. Standard palliative radiotherapy regimens provide limited durability of response, and there are challenges with delivery to large tumors or in previously irradiated fields. In this study, Proton GRID radiotherapy will be used to deliver three-fraction palliative radiotherapy to patients with tumors needing palliative radiation. The safety and efficacy of this approach will be assessed. It is hypothesized that GRID is highly effective, immunogenic, and associated with low rates of toxicity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed cancer diagnosis.
Planning to undergo palliative radiotherapy to unresectable or metastatic target lesion ≥ 4.5 cm in any dimension as measured with radiographic imaging or with calipers by clinical exam.
Cohort A: 10 patients with lesions that have been previously irradiated.
Cohort B: 10 patients with lesions that have not been previously irradiated.
Disqualifiers
Patients with tumors in need of urgent surgical intervention, such as life-threatening bleeding or those at high risk for pathologic fracture and amenable to surgical intervention.
Patients with a superficial target lesion ≤ 1 cm deep to skin surface who initially had a superficial lesion irradiated, if the target lesion was in the area of the prior irradiation.
Currently receiving any cytotoxic cancer therapy regimens or VEGF inhibitors that will overlap with the proton GRID 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.
Trial design
Design model
Sequential
Treatments tested in this trial
Proton GRID Radiotherapy
RadiationThe proton GRID radiotherapy prescription dose is 20 Gy x 3 fractions to the tumor, with an integrated dose of 6 Gy x 3 fractions to the PTV. Treatment to multiple lesions within the PTV is allowed (ex. a dominant lesion plus satellites). Multiple proton GRID radiotherapy plans may be delivered on the same day or different days, but they cannot overlap.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Cohort A: Reirradiation of Treatment FieldsExperimental treatment 1 intervention
Group B: Cohort B: De Novo Radiation Treatment FieldsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Rate of treatment-related acute toxicity
-Grade per CTCAE v5.0.
Time frame
From start of treatment through 90 days2
Rate of treatment-related late toxicity
-Grade per CTCAE v5.0.
Time frame
From day 91 through 12 monthsSecondary outcomes
1
Change in PRO-CTCAE (General Inventory and Disease Specific Inventory Assessment)
PRO-CTCAE is a standardized inventory to collected patient reported symptomatic adverse events in clinical trials.
Time frame
Baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days2
Change in PROMIS Global Health
PROMIS Global Health is a 10-item patient-reported questionnaire that assesses health related quality of life compared with normal values for the general population with the response options presented as a 5-point (as well as a single 11-point) rating scale. The question that uses an 11-point scale uses a response scale of 0-10 that is recoded to 5 categories (0 = 1; 1-3 = 2; 4-6 = 3; 7-9 = 4; 10 = 5). The results of the questions are used to calculate two summary scores: a Global Physical Health Score and a Global Mental Health score. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores are indicative of a healthier patient.
Time frame
Baseline, at last day of radiotherapy (day 3), within 2 weeks after completion of radiotherapy (day 14), 30 days, 90 days, 180 days, and 360 days3
Rate of target lesion local control
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov