Clinical trial · Interventional
5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases
A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases
- 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 prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule. The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.
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 |
|---|---|---|---|
| Solid Tumors With Oligometastatic Spread | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Stereotactic Body Radiation Therapy
- description
- All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
- interventionNames
- Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance
Primary outcomes (1)
- measure
- Proportion of patients with lack of progressive disease for the index site at 1 year
- timeFrame
- 10 years
- description
- CT will be used for evaluation of the status of the local disease at the index site.
Secondary outcomes (7)
- measure
- Number of index lesion(s) with lack of progressive disease at 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded. * Histological confirmation of neoplastic disease either from original primary or metastatic sites is required. * Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory. * Oligometastatic disease, maximum of 5 lesions. * At least one lesion is suitable for stereotactic body radiotherapy * All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months * ECOG ≤ 2 * At least 18 yrs old Exclusion Criteria: * Previous radiotherapy to the intended treatment site * Patient cannot tolerate physical set up required for SBRT * Active bowel obstruction, if treating abdominal/pelvic site * Chemotherapy within 2 weeks of intended radiation therapy * Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved * Pregnancy
References
Publications (0)
Data not yet available