Clinical trial · Interventional
Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors
A Phase 1 Study of Proton Pencil Beam Scanning GRID for Treatment of Bulky Tumors (ProGRID)
NCT05121545CI-TRIAL-00101921ProGRIDactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a single arm, phase I study, evaluating the feasibility, toxicity, and degree of tumor response after novel proton pencil beam scanning (PBS GRID) treatment in patients with bulky tumors that are difficult to manage.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pro-GRID | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Pro-GRID treatment Arm
- description
- Patients enrolled in this study will receive spatially-fractionated radiotherapy or GRID-therapy, which involves delivering a one-time treatment of high dose radiation to small amounts of tumor in a manner that creates alternating regions of high and low dose radiation within the tumor. Patients will receive 2 (lowest dose) to 18 Gy (highest dose) in a single fraction.
- interventionNames
- Radiation: Pro-GRID
Primary outcomes (1)
- measure
- Feasibility of the Pro-GRID intervention as assessed by success of intervention delivery for a number of participants
- timeFrame
- 1.5 years
- description
- To assess the feasibility of successfully creating treatment plans and delivering a novel proton therapy called Pro-GRID. Feasibility will be determined by a successful intervention delivery for 10 of 12 patients with bulky solid tumors.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 * Histologically or cytologically confirmed invasive cancer * Bulky tumor \> 7 cm, determined clinically and/or radiographically, at the time of evaluation prior to enrollment * Treated indicated for palliative intent * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Anticipated treatment deemed safe on pre-review by PI * For patients with prior Radiation Therapy (RT): Dicoms must be available for dose fusion if overlap anticipated with GRID * Willing and able to provide informed consent * Discussion with medical oncology or surgical specialty Exclusion Criteria: * Age \< 18 * ECOG performance status 3-4 * Planned for definitive, curative management * For patients with prior RT that overlaps with Pro-GRID: Dicoms not available Pregnant women * Tumor encasing critical structure, as defined by the treating MD.
References
Publications (0)
Data not yet available
No reference posted for this study.