Solid tumour Cancer
Conditions
Interventions
Lattice Radiation Therapy: Spatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT) in five fractions to discrete sub-volumes within a tumor
Once enrolled in the study, the patients
Sponsors
University Health Network
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of solid tumor by at least one criterion below: 1.1. Pathologically or cytologically proven solid tumor greater than 5 cm (largest dimension) from a primary site or site of metastasis and unsuitable for surgical resection or definitive RT 1.2. HCC diagnosed by standard imaging criteria permitted: arterial enhancement and delayed washout on multiphasic computerized tomography (CT) or magnetic resonance imaging (MRI) in the setting of cirrhosis or chronic hepatitis B or C without cirrhosis 2. Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization 3. In the investigator’s opinion, patient requires palliative radiation therapy to a lesion >5 cm measured in one of the following ways: 3.1. Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST) 3.2. CT simulation performed for radiation planning 4. Able to understand and provide written consent 5. Willing and have the ability to complete the baseline and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary 6. Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days 7. Patient must be accessible for treatment and follow-up. Investigators must ensure the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up
Exclusion criteria
Exclusion criteria: 1. Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment 2. Requirement for urgent surgical intervention prior to radiation treatment 3. Confirmed pregnancy 4. Hematologic primary malignancy 5. Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder) 6. Tumors overlying critical CNS, heart or spinal cord compression
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using international consensus for pain response (ICPR) at baseline and 30 +/-7 days following treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain response pattern measured using ICPRE at 1, 3, and 6 months post RT 2. Reirradiation rate is measured by counting the number of patients receiving reirradiation within 6 months following radiotherapy 3. Treatment-related toxicity is measured using Common Terminology Criteria for Adverse Events (CTCAE) v5 at baseline, after treatment, and at 1, 3 and 6 months after treatment 4. Objective tumour response is measured using RECIST with the CT scans at baseline and at 3 and 6 months post-treatment 5. Overall survival and progression-free survival measured from randomization to progression at any site or death 6. Quality of life is measured using the EORTC-QLQ C30 questionnaire at baseline, after radiation treatment, and at 1, 3, and 6 months post-treatment | — |
Countries
Canada
Contacts
Public ContactJelena Lukovic
Outcome results
None listed