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

October 5, 2021 updated by: Michele Tedeschi, Istituto Clinico Humanitas

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Investigators

  • Principal Investigator: Ciro Franzese, MD, Istituto Clinico Humanitas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2015

Primary Completion (Actual)

March 26, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

September 28, 2015

First Submitted That Met QC Criteria

October 5, 2015

First Posted (Estimate)

October 7, 2015

Study Record Updates

Last Update Posted (Actual)

October 6, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 1388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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