What this study is
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.
What's being tested
- Lattice Radiation Therapy (LRT)
Intervention · RADIATION
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.
Study details
- Official title
- Pilot Study of Lattice Radiotherapy in Adults With Large Tumors
- Sponsor
- Duke University
- Conditions
- Large Tumor · Palliative Radiotherapy
- Enrolling
- 25 people
- Starts
- 2027-01-01
- Est. completion
- 2031-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke Cancer Center
Durham, North Carolina, United States
- Duke Radiation Oncology Clinical Trials · Contact919-668-3726RadOnc-Clinical_Trials@dm.duke.edu
- Trey Mullikin, MD · Principal investigator
Study team
Sponsor
Duke University
Study ID Pro00120554
Principal investigator
Trey Mullikin, MD
Duke Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.