5 Fraction Stereotactic Body Radiation Therapy for Oligometastases Regimen, for Extra-Cranial Oligometastases

Phase 2

Completed

• Conditions: Solid Tumors With Oligometastatic Spread

• Registration Number: NCT01761929
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

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 Timeline

• Study First Submitted: 2012-02-27
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-07
• Study Start: 2013-03-07
• Primary Completion: 2023-02-08
• Study Completion: 2023-02-08
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to local progression for the index site(s)	10 years
Acute toxicity within 90 days of first fraction of radiotherapy	10 years	Acute toxicity will be graded according to the Common Toxicity Criteria, v4.0
Time to distant disease progression (beyond known sites of oligometastases at time of study entry)	10 years
Describe symptom profile	10 Years
Examine radiotherapy parameters (outlined in Appendix J) for local control of index site(s) and toxicities	10 years
Number of index lesion(s) with lack of progressive disease at 1 year.	10 years	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.
Late toxicity occuring beyond 90 days related to SBRT.	10 year	Late toxicity will be graded according to the Radiation Therapy Oncology Group/ European Organization for Research and Treatment of Cancer score.

Trial Locations

Locations (1)

University Health Network, Princess Margaret Cancer Center; 🇨🇦 Toronto, Ontario, Canada