Large Tumor, Palliative Radiotherapy
Conditions
Keywords
palliative radiation therapy, large tumor, lattice radiation therapy (LRT)
Brief summary
The purpose of this study is to ask whether using a specialized radiation therapy technique called Lattice Radiation Therapy (LRT) can shrink large tumors when given with palliative radiation therapy. The primary questions are: * if LRT is safe and does not worsen existing side effects or cause new side effects * if adding LRT to standard radiation therapy can improve tumor shrinkage. Participants will have one additional radiation treatment (LRT) prior to starting palliative radiation and then their progress will be followed for one year.
Interventions
RADIATIONLattice Radiation Therapy (LRT)
Lattice Radiation Therapy (LRT) is a specialized form of Intensity-Modulated Radiation Therapy (IMRT) designed to provide focused radiation to the deepest part of large tumors.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed malignancy diagnosis * Radiographic evidence of large extracranial tumor (≥ 4.5 cm) * Patients with primary or metastatic extracranial tumors may be included * Planned to undergo palliative radiation treatment * Life expectancy of at least 3 months * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3 * Patient must sign study-specific informed consent
Exclusion criteria
* Primary lesion with radiosensitive histology (i.e. germ cell tumors, lymphoma, leukemia, and multiple myeloma) * Prior radiation treatment that overlaps with any planned site of protocol radiotherapy that would preclude further palliative RT. * Receiving concurrent cytotoxic cancer therapy regimens or Vascular Endothelial Growth Factor (VEGF) inhibitor that would overlap with LRT administration. Cytotoxic chemotherapy, targeted therapies, small molecule inhibitors, or sVEGF inhibitors prior to radiation treatment or planned after radiation delivery are allowed at the discretion of the treating radiation oncologist.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiotherapy (RT) treatment-related, non-hematologic Common Terminology Criteria for Adverse Events (CTCAE) v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 90 days | 90 days | Incidence reported as the number of events divided by the study population. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months | 12 months | Incidence reported as the number of events divided by the study population. |
| Tumor response as measured by change in volume | 3 months, 6 months, 12 months | — |
| Tumor response as measured by change in largest dimension (maximal diameter) | 3 months, 6 months, 12 months | — |
Countries
United States
Contacts
CONTACTHeather Franklin, RN BSN OCN
PRINCIPAL_INVESTIGATORTrey Mullikin, MD
Duke Health
Outcome results
None listed