Lattice Radiotherapy for Adults With Large Tumors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDuke University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Lattice Radiation Therapy (LRT)
RadiationLattice 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Lattice Radiation Therapy (LRT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Incidence reported as the number of events divided by the study population.
Time frame
90 daysSecondary outcomes
1
Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months
Incidence reported as the number of events divided by the study population.
Time frame
12 months2
Tumor response as measured by change in volume
Time frame
3 months, 6 months, 12 months3
Tumor response as measured by change in largest dimension (maximal diameter)
Time frame
3 months, 6 months, 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: