Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial

European Organisation for Research and Treatment of Cancer - EORTC13 sites in 7 countries200 target enrollmentJune 10, 2021

ConditionsGynecologic Cancer Skin Cancer Head and Neck Cancer Sarcoma Renal Cancer Bladder Cancer Upper Urinary Tract Carcinoma Pancreatic Cancer Hepatobiliary Cancer Gastric Cancer Small Bowel Cancer Esophageal Cancer Melanoma Colon Cancer Oligometastasis

Overview

Phase: N/A
Intervention: Not specified
Conditions: Gynecologic Cancer
Sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Enrollment: 200
Locations: 13
Primary Endpoint: Overall survival
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.

Patients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.

The primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.

Registry

clinicaltrials.gov

Start Date

June 10, 2021

End Date

February 1, 2030

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.
•Controlled primary tumour, defined as:
•at least 3 months since original tumour treated definitively, with no progression at primary site
•Total number of oligometastases of 1-5 including:
•Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases
•All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist
•ECOG score 0-2
•Life expectancy \> 6 months
•Age 18 or older
•Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations.

Exclusion Criteria

•Primary cancer of prostate, breast, lung or colorectal
•Serious medical comorbidities precluding radiotherapy:
•These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.
•For patients with liver metastases, moderate/severe liver dysfunction (Child Pugh B or C)
•Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators
•Brain metastases only, without extra-cerebral metastases
•Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis
•Maximum size of 6 cm for lesions outside the brain, except:
•Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)
•Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.

Outcomes

Primary Outcomes

Overall survival

Time Frame: 7.5 years from first patient in

Overall survival is the time interval from the date of randomization to the date of death whatever the cause of death. Patients who are alive are censored at the last date known to be alive.

Secondary Outcomes

Time to disease progression(9 years from first patient in)
Time to development of new metastatic lesions(9 years from first patient in)
Disease-specific survival(9 years from first patient in)
Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires(9 years from first patient in)
Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0(9 years from first patient in)
Progression-free survival(9 years from first patient in)
Time to development of polymetastatic disease(9 years from first patient in)
Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires(9 years from first patient in)