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

NCT ID: NCT02570399

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-26
• Study Completion Date: 2022-12-31

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.

Conditions

Lymph Node Cancer Metastatic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lymph nodal metastatic lesions

Oligometastatic patients with abdominal-pelvic lymph nodes

Group Type: EXPERIMENTAL

Oligometastatic patients with abdominal-pelvic lymph nodes

Intervention Type: RADIATION

Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases

Interventions

Oligometastatic patients with abdominal-pelvic lymph nodes

Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Michele Tedeschi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ciro Franzese, MD

Role: PRINCIPAL_INVESTIGATOR

Istituto Clinico Humanitas

Locations

Istituto Clinico Humanitas

Rozzano, Milano, Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 32556682 (View on PubMed)

Other Identifiers

1388

Identifier Type: -

Identifier Source: org_study_id