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

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Solid Tumors With Oligometastatic Spread

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT01761929

UHN REB '11-0886-C'

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Stereotactic Body Radiation Therapy

Experimental group

Description:

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.

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