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

NCT02570399 | Unknown DMC

• 1 other identifier: 1388
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymph Node Cancer Metastatic

Outcome Measures

Primary Outcomes (1)

• Feasibility in terms of toxicity related to radiation therapy

  Evaluation of acute and late toxicity performed during and after radiation therapy

  2 months

Secondary Outcomes (4)

• Tumour response to local radiation therapy (RECIST criteria)

  2 months

• Overall survival in the oligometastatic patients

  2 months

• Disease free survival in the oligometastatic patients

  2 months

• Quality of life questionnaire of treated patients

  2 months

Study Arms (1)

Lymph nodal metastatic lesions

EXPERIMENTAL

Oligometastatic patients with abdominal-pelvic lymph nodes

Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes

Interventions

Oligometastatic patients with abdominal-pelvic lymph nodes RADIATION

Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases

Lymph nodal metastatic lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead

Study Sites (1)

Istituto Clinico Humanitas

Rozzano, Milano, 20089, Italy

Location

Related Publications (1)

• 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.

  PMID: 32556682 DERIVED

Study Officials

• Ciro Franzese, MD

  Istituto Clinico Humanitas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: October 7, 2015
• Study Start: February 26, 2015
• Primary Completion: March 26, 2019
• Study Completion: December 1, 2022
• Last Updated: October 6, 2021

Record last verified: 2021-10

Locations

IT (1)