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

• Sponsor: Istituto Clinico Humanitas (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT02570399
• Collaborator: (none)
• Enrollment: 55
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 93.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymph Node Cancer Metastatic	Radiation: Oligometastatic patients with abdominal-pelvic lymph nodes	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 55 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 26, 2015
• Actual Primary Completion Date: Mar 26, 2019
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Tumour response to local radiation therapy (RECIST criteria) [2 months]

   Evaluation of tumour response to local radiation therapy by means of imaging

2. Overall survival in the oligometastatic patients [2 months]

   Statistical evaluation of how local control of the metastatic disease can affect overall survival

3. Disease free survival in the oligometastatic patients [2 months]

   Statistical evaluation of how local control of the metastatic disease can affect disease free survival

4. Quality of life questionnaire of treated patients [2 months]

   Evaluation of quality of life of patients during and after radiation therapy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Clinico Humanitas	Rozzano	Milano	Italy	20089

Sponsors and Collaborators

• Istituto Clinico Humanitas

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michele Tedeschi, MD, Istituto Clinico Humanitas
• ClinicalTrials.gov Identifier: NCT02570399
• Other Study ID Numbers: 1388
• First Posted: Oct 7, 2015
• Last Update Posted: Oct 6, 2021
• Last Verified: Oct 1, 2021

Study Results

No Results Posted as of Oct 6, 2021