High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients

Istituto Clinico Humanitas

Status

Unknown

Conditions

Lymph Node Cancer Metastatic

Treatments

Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes

Study type

Interventional

Funder types

Other

Identifiers

NCT02570399

1388

Details and patient eligibility

About

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.

Full description

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.

Enrollment

55 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.