Clinical trial · Interventional
High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients
Feasibility Study of High Dose Stereotactic Body Radiation Therapy (SBRT) for Lymph Nodal Lesions in Oligometastatic Patients for Genito-urinary, Gastro-intestinal and Gynaecological Cancer
NCT02570399CI-TRIAL-00054300unknownN/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 prospective, multicentric, phase II and feasibility study aimed to address early and late side effects of hypofractionated ablative radiotherapy for oligometastatic patients with lymph node metastases for genito-urinary, gastro-intestinal and gynaecological cancer.
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 |
|---|---|---|---|
| Lymph Node Cancer Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oligometastatic patients with abdominal-pelvic lymph nodes | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymph nodal metastatic lesions
- description
- Oligometastatic patients with abdominal-pelvic lymph nodes
- interventionNames
- Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes
Primary outcomes (1)
- measure
- Feasibility in terms of toxicity related to radiation therapy
- timeFrame
- 2 months
- description
- Evaluation of acute and late toxicity performed during and after radiation therapy
Secondary outcomes (4)
- measure
- Tumour response to local radiation therapy (RECIST criteria)
- timeFrame
- 2 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years * WHO performance status ≤ 2 * Histologically-proven of primary cancer disease * M1 stage with primary cancer site radically treated with complete response/resection or stable. No other site of disease in progression (a maximum of 3 lymph node sites of disease to treat) * Diameter ≤ 5 cm * Abdomen/pelvic site * Informed consent. Exclusion Criteria: * Patients were required to have not brain metastases or bone metastases. * Patients with a life expectancy of \>3 months. * Any serious disease contraindicated radiation therapy * Other coexisting malignancies, uncontrolled intercurrent illness, active infectious processes, and exudative, bloody, or cytologically malignant effusions excluded patients from the trial. Additionally, patients were excluded from the trial if they were receiving any systemic chemotherapy during radiotherapy, although hormonal therapy was allowed.
References
Publications (1)
- DERIVEDFranzese C, Comito T, Tripoli A, Franceschini D, Clerici E, Navarria P, Badalamenti M, D'agostino G, Loi M, Mancosu P, Reggiori G, Tomatis S, Scorsetti M. Phase II trial of high dose stereotactic body radiation therapy for lymph node oligometastases. Clin Exp Metastasis. 2020 Oct;37(5):565-573. doi: 10.1007/s10585-020-10047-x. Epub 2020 Jun 15. PMID 32556682