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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Lymph Node Cancer Metastatic

Intervention / Treatment
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* Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lymph nodal metastatic lesions<br>Oligometastatic patients with abdominal-pelvic lymph nodes | Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes<br>* Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility in terms of toxicity related to radiation therapy | Evaluation of acute and late toxicity performed during and after radiation therapy | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour response to local radiation therapy (RECIST criteria) | Evaluation of tumour response to local radiation therapy by means of imaging | 2 months | 
| Overall survival in the oligometastatic patients | Statistical evaluation of how local control of the metastatic disease can affect overall survival | 2 months | 
| Disease free survival in the oligometastatic patients | Statistical evaluation of how local control of the metastatic disease can affect disease free survival | 2 months | 
| Quality of life questionnaire of treated patients | Evaluation of quality of life of patients during and after radiation therapy | 2 months |