Clinical trial · Interventional
High Dose Radiotherapy for Palliation (Hi-D)
A Prospective Study of High Dose Radiotherapy for Palliation: Hi-D
NCT07291895CI-TRIAL-00121628not yet 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)
Palliative radiation is effective for controlling or preventing symptoms such as pain, bleeding, dyspnea, and cord compression. Recently, studies have shown that additional dose escalation may result in superior local control. The investigators propose a phase II single arm trial to evaluate a novel high-dose radiation regimen, which will be 27 Gray in 3 fractions with dose escalation within the tumour (Hi-D).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastases | — | UNRESOLVED | — |
| Palliative Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Palliative Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High-Dose RT
- description
- 27Gy in 3 fractions with boost
- interventionNames
- Radiation: Palliative Radiotherapy
Primary outcomes (1)
- measure
- Local Control
- timeFrame
- 4 years, with 2 years of accrual and 2 years of follow up
- description
- to determine the length of time from treatment to tumor growth, recurrence, or progression at radiated sites achieved when using high-dose palliative radiotherapy
Secondary outcomes (6)
- measure
- Overall Survival
- timeFrame
- 4 years, with 2 years of accrual and 2 years of follow up.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
5.1. Inclusion Criteria Subjects must meet all of the following criteria to be eligible for participation in this study: * Age 18 or older. * Able to provide informed consent * Patient has histologically confirmed solid tumour malignancy * ECOG performance status 0 - 2 * Life Expectancy \> 6 months * Locally advanced or metastatic disease with 1-3 target lesions larger than 5cm in minimum dimension, with no more than 2 target lesions in a single organ; patients can have any number of non-target lesions * A history and physical exam, including ECOG performance status, performed within 6 weeks prior to trial enrollment * Not suitable for or declined curative-intent treatment * Subject has had a CT chest, abdomen and pelvis or PET-CT within 8 weeks prior to enrollment, and with 12 weeks of treatment * MRI spine for patients receiving RT to vertebral or paraspinal metastases * Patient is judged able to: * Maintain a stable position during therapy * Tolerate immobilization device(s) that may be required to deliver radiation safely 5.2. Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply: * Hematologic malignancy * Disease limited to intracranial sites * Serious medical co-morbidities precluding radiotherapy * Prior radiation to target lesion that precludes delivery of repeat radiation. All such cases should be discussed with the local and study PIs. * Pregnant people
References
Publications (0)
Data not yet available
No reference posted for this study.