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

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.

The purpose of this prospective, multicentric, phase II study is to determine the feasibility of Stereotactic Body Radiation Therapy in stage IV selected oligometastatic patients, by looking at acute and late toxicity. Investigators also want to verify what is the impact of local control in irradiated metastatic foci in the context of the systemic disease, how local control can affect disease free survival and overall survival, and moreover quality of life of patients treated.

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.