Clinical trial NCT04498767: Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Official title: Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gynecologic 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
Keywords: oligometastatic cancer
Stereotactic body radiotherapy
SBRT
Lead sponsor: European Organisation for Research and Treatment of Cancer - EORTC
Sponsor class: NETWORK
Collaborators: name: Anticancer Fund, Belgium
name: Rising Tide Foundation
First posted: 2020-08-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis
* Pregnant or breast feeding women
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial

Primary outcomes:
measure: Overall survival
timeFrame: 7.5 years from first patient in
Secondary outcomes:
measure: Progression-free survival
timeFrame: 9 years from first patient in
measure: Disease-specific survival
timeFrame: 9 years from first patient in
measure: Time to disease progression
timeFrame: 9 years from first patient in
measure: Time to development of new metastatic lesions
timeFrame: 9 years from first patient in
measure: Time to development of polymetastatic disease
timeFrame: 9 years from first patient in
measure: Adverse events graded according to the National Cancer Institute Common Terminology Criteria for adverse events (NCI-CTCAE) version 5.0
timeFrame: 9 years from first patient in
measure: Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires
timeFrame: 9 years from first patient in
measure: Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires
timeFrame: 9 years from first patient in
Other outcomes:
Locations:
city: Anderlecht
country: Belgium
facility: Institut Jules Bordet
city: Gent
country: Belgium
facility: Universitair Ziekenhuis Gent
city: Wilrijk
country: Belgium
facility: Gasthuiszusters Antwerpen - Sint-Augustinus
city: Lille
country: France
facility: Centre Oscar Lambret
city: Villejuif
country: France
facility: Gustave Roussy
city: Hamburg
country: Germany
facility: Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
state: Martinistrasse 52
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
city: Gdansk
country: Poland
facility: Medical University Of Gdansk
state: Mariana Smoluchowskiego 17
city: Warsaw
country: Poland
facility: Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
city: Bern
country: Switzerland
facility: Inselspital
city: Zurich
country: Switzerland
facility: UniversitaetsSpital Zurich
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
city: London
country: United Kingdom
facility: Royal Marsden Hospital - site: Chelsea, London
Study officials:
affiliation: University of Zurich
name: Matthias Guckenberger
role: PRINCIPAL_INVESTIGATOR
affiliation: Gasthuiszusters Antwerpen - Sint-Augustinus
name: Piet Ost
role: PRINCIPAL_INVESTIGATOR
References: