5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases (5fr SBRT)

A Phase II Study on the Toxicity and Efficacy of a Normal Tissue Tolerance Adapted, 5 Fraction Stereotactic Body Radiation Therapy (SBRT) Regimen, for Extra-Cranial Oligometastases

This is a prospective Phase II study.The purpose of this study is to monitor the side effects and treatment outcomes of delivering higher doses of radiation therapy to the tumour, while limiting the dose of radiation to the normal tissues. This will be done using a 5 day treatment schedule.

The characteristics of patients whose disease remains confined to limited areas in the long term, compared with those who do not will also be described.

Study Overview

• Status: Completed
• Conditions: Solid Tumors With Oligometastatic Spread
• Intervention / Treatment: Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance

Detailed Description

Endpoints are to describe: the proportion of patients with local control for the index site at 1 year; the number of index lesion(s) with local control at 1 year; acute and late AEs related to SBRT; time to local progression for the index site; time to distant disease progression; symptom and QoL profile; median survival.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Any solid tumors are eligible. Lymphoma, myeloma and germ cell tumors are excluded.
• Histological confirmation of neoplastic disease either from original primary or metastatic sites is required.
• Radiological diagnosis of oligometastastic metastatic disease is accepted if considered clinically acceptable. Histological confirmation is not mandatory.
• Oligometastatic disease, maximum of 5 lesions.
• At least one lesion is suitable for stereotactic body radiotherapy
• All known sites of disease have plans for local ablative management (see section management plan for definitions) within 3 months
• ECOG ≤ 2
• At least 18 yrs old

Exclusion Criteria:

• Previous radiotherapy to the intended treatment site
• Patient cannot tolerate physical set up required for SBRT
• Active bowel obstruction, if treating abdominal/pelvic site
• Chemotherapy within 2 weeks of intended radiation therapy
• Treatment plan respecting normal tissue tolerances using dose fractionation specified within the protocol cannot be achieved
• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stereotactic Body Radiation Therapy; All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.	Radiation: Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance; All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with lack of progressive disease for the index site at 1 year	CT will be used for evaluation of the status of the local disease at the index site.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of index lesion(s) with lack of progressive disease at 1 year.	The Modified Response Evaluation Criteria for solid Tumors (RECIST) will be used. By measuring the longest diameter (LD) of the lesions, response of individual lesions and overall response will be documented.	10 years
Acute toxicity within 90 days of first fraction of radiotherapy	Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0	10 years
Time to local progression for the index site(s)		10 years
Time to distant disease progression (beyond known sites of oligometastases at time of study entry)		10 years
Late toxicity occuring beyond 90 days related to SBRT.	Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.	10 year
Describe symptom profile		10 Years
Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities		10 years

Other Outcome Measures

Outcome Measure	Time Frame
Explore pre-treatment prognostic factors derived from clinical data and correlative studies for disease free interval	10 years
Explore pre-treatment prognostic factors derived from clinical data and correlative studies for local control of index site(s) at 1 year	10 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: Rebecca K.S. Wong, MB ChB, University Health Network - Princess Margaret Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2013
• Primary Completion (Actual): February 8, 2023
• Study Completion (Actual): February 8, 2023

Study Registration Dates

• First Submitted: February 27, 2012
• First Submitted That Met QC Criteria: January 3, 2013
• First Posted (Estimated): January 7, 2013

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: radiotherapy; radiation therapy; stereotactic body radiotherapy; Oligometastasis; oligometastatic; oligometastases; Stereotactic ablative body
• Additional Relevant MeSH Terms: MAX protein, human
• Other Study ID Numbers: 11-0886