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

Lymph Node Cancer Metastatic Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02570399
• Other study ID #: 1388
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 26, 2015
• Est. completion date: December 2022

Study information

• Verified date: October 2021
• Source: Istituto Clinico Humanitas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 2022
• Est. primary completion date: March 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymph Node Cancer Metastatic

Intervention

Radiation:
• Oligometastatic patients with abdominal-pelvic lymph nodes
Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility in terms of toxicity related to radiation therapy	Evaluation of acute and late toxicity performed during and after radiation therapy	2 months
Secondary	Tumour response to local radiation therapy (RECIST criteria)	Evaluation of tumour response to local radiation therapy by means of imaging	2 months
Secondary	Overall survival in the oligometastatic patients	Statistical evaluation of how local control of the metastatic disease can affect overall survival	2 months
Secondary	Disease free survival in the oligometastatic patients	Statistical evaluation of how local control of the metastatic disease can affect disease free survival	2 months
Secondary	Quality of life questionnaire of treated patients	Evaluation of quality of life of patients during and after radiation therapy	2 months