Clinical trial NCT02570399: High Dose SBRT for Abdominal-Pelvic Lymph Nodal Lesions in Oligometastatic Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymph Node Cancer Metastatic
Lead sponsor: Istituto Clinico Humanitas
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility in terms of toxicity related to radiation therapy
timeFrame: 2 months
Secondary outcomes:
measure: Tumour response to local radiation therapy (RECIST criteria)
timeFrame: 2 months
measure: Overall survival in the oligometastatic patients
timeFrame: 2 months
measure: Disease free survival in the oligometastatic patients
timeFrame: 2 months
measure: Quality of life questionnaire of treated patients
timeFrame: 2 months
Other outcomes:
Locations:
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
state: Milano
Study officials:
affiliation: Istituto Clinico Humanitas
name: Ciro Franzese, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franzese 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.