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

NCT ID: NCT01761929

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-07
• Study Completion Date: 2023-02-08

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.

Conditions

Solid Tumors With Oligometastatic Spread

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: RADIATION

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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rebecca K.S. Wong, MB ChB

Role: PRINCIPAL_INVESTIGATOR

University Health Network - Princess Margaret Cancer Center

Locations

University Health Network, Princess Margaret Cancer Center

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

UHN REB '11-0886-C'

Identifier Type: -

Identifier Source: org_study_id