Lattice Radiotherapy for Adults With Large Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lattice Radiation Therapy (LRT).
- Who it may be relevant to
- Registry conditions: Large Tumor, Palliative Radiotherapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pilot Study of Lattice Radiotherapy in Adults With Large Tumors
Overview
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
- Radiation Lattice 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.
Primary outcome measures
- 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 [Time frame: 90 days]
Secondary outcome measures (3)
- Incidence of Radiotherapy (RT) treatment-related, non-hematologic CTCAE v6.0 Grade ≥ 3 toxicity and Adverse Events of Special Interest (AESI) at 12 months [Time frame: 12 months]
- Tumor response as measured by change in volume [Time frame: 3 months, 6 months, 12 months]
- Tumor response as measured by change in largest dimension (maximal diameter) [Time frame: 3 months, 6 months, 12 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Duke Cancer Center — Durham
Identifiers
NCT: NCT07647679 · Pro00120554