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

Not Applicable

• Conditions: Lymph Node Cancer Metastatic
• Interventions: Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes

• Registration Number: NCT02570399
• Lead Sponsor: Istituto Clinico Humanitas

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.

Study Timeline

• Study Start: 2015-02-26
• Study First Submitted: 2015-09-28
• Study First Submitted QC: 2015-10-05
• Study First Posted: 2015-10-07
• Primary Completion: 2019-03-26
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymph nodal metastatic lesions	Oligometastatic patients with abdominal-pelvic lymph nodes	Oligometastatic patients with abdominal-pelvic lymph nodes

Primary Outcome Measures

Name	Time	Method
Feasibility in terms of toxicity related to radiation therapy	2 months	Evaluation of acute and late toxicity performed during and after radiation therapy

Secondary Outcome Measures

Name	Time	Method
Tumour response to local radiation therapy (RECIST criteria)	2 months	Evaluation of tumour response to local radiation therapy by means of imaging
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
Overall survival in the oligometastatic patients	2 months	Statistical evaluation of how local control of the metastatic disease can affect overall survival

Trial Locations

Locations (1)

Istituto Clinico Humanitas; 🇮🇹 Rozzano, Milano, Italy