Clinical trial · Interventional
Lattice Radiation Therapy Versus Conventional Radiation Therapy for the Palliation of Large Tumors
NCT07444775CI-TRIAL-00104505LATTICE-PALrecruitingPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 17, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260917-000001
Summary
Brief summary (as posted)
The goal of this randomized, phase III trial is to to determine if Spatially Fractionated Lattice Radiotherapy (SFRT) known as LATTICE therapy, leads to a greater reduction in pain or discomfort compared with conventional Radiation Therapy (RT) in patients with large tumours. This is evaluated by assessing if a greater proportion of patients who receive RT with SFRT will have an improvement in pain/discomfort at 30 days defined using the International Consensus Pain Response (ICPR) compared with those treated with conventional RT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Histopathologically or Cytologically Confirmed Solid Tumor Who Require Palliation Radiation Therapy to a Lesion ≥5cm | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Radiation Therapy | Radiation | — | UNRESOLVED |
| Spatially fractionated radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A "Conventional Radiation Therapy"
- description
- Homogenous RT (20Gy to 35Gy in 5 fractions), planned using volumetric modulated arc therapy or 3D conformal radiotherapy (3DCRT)
- interventionNames
- Radiation: Conventional Radiation Therapy
- type
- EXPERIMENTAL
- label
- Arm B "Lattice Radiation Therapy"
- description
- Spatially fractionated radiation therapy, via LATTICE Radiotherapy (LRT), 20Gy in 5 fractions with boost of 67Gy in 5 fractions with boost of 67Gy in 5 fractions to discrete sub-volumes within a tumour
- interventionNames
- Radiation: Spatially fractionated radiation therapy
Primary outcomes (1)
- measure
- Response in pain
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of solid tumor by at least one criterion below: a. 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. b. 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 * Eastern Cooperative Oncology Group (ECOG) Status: 0-4 within 14 days of randomization * In the investigator's opinion, patient requires palliative radiation therapy to a lesion \>5 cm measured in one of the following ways: * Imaging performed within 90 days prior to randomization per Response Evaluation Criteria in Solid Tumors (RECIST) * CT simulation performed for radiation planning * Able to understand and provide written consent * Willing and have the ability to complete the baseline and post-treatment questionnaires (short form brief-pain inventory) and to maintain a pain diary * Patient is not pregnant, planning on becoming pregnant or planning on fathering a child in the next 90 days * 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 * Minimum worst pain score of 2/10 in the past 24 hours on the Brief Pain Inventory. Exclusion Criteria: * Prior radiotherapy that would result in substantial overlap of the irradiated volume thus precluding per protocol treatment * Requirement for urgent surgical intervention prior to radiation treatment * Confirmed pregnancy * Hematologic primary malignancy * Medical condition precluding the delivery of per protocol treatment (e.g. connective tissue disorder) * Tumors overlying critical CNS, heart or spinal cord compression
References
Publications (0)
Data not yet available
No reference posted for this study.