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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Feasibility in terms of toxicity related to radiation therapy
Evaluation of acute and late toxicity performed during and after radiation therapy
Time frame: 2 months
Tumour response to local radiation therapy (RECIST criteria)
Evaluation of tumour response to local radiation therapy by means of imaging
Time frame: 2 months
Overall survival in the oligometastatic patients
Statistical evaluation of how local control of the metastatic disease can affect overall survival
Time frame: 2 months
Disease free survival in the oligometastatic patients
Statistical evaluation of how local control of the metastatic disease can affect disease free survival
Time frame: 2 months
Quality of life questionnaire of treated patients
Evaluation of quality of life of patients during and after radiation therapy
Time frame: 2 months
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