Lymph Node Cancer Metastatic
Conditions
Brief summary
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.
Detailed 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.
Interventions
RADIATIONOligometastatic patients with abdominal-pelvic lymph nodes
Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases
Sponsors
Istituto Clinico Humanitas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility in terms of toxicity related to radiation therapy | 2 months | Evaluation of acute and late toxicity performed during and after radiation therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumour response to local radiation therapy (RECIST criteria) | 2 months | Evaluation of tumour response to local radiation therapy by means of imaging |
| Overall survival in the oligometastatic patients | 2 months | Statistical evaluation of how local control of the metastatic disease can affect overall survival |
| Disease free survival in the oligometastatic patients | 2 months | Statistical evaluation of how local control of the metastatic disease can affect disease free survival |
| Quality of life questionnaire of treated patients | 2 months | Evaluation of quality of life of patients during and after radiation therapy |
Countries
Italy
Outcome results
None listed