Menu
Recruiting NCT04498767

Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)

No phase Interventional Gynecologic Cancer Skin Cancer Head and Neck Cancer Sarcoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stereotactic body radiotherapy, Palliative RT.
Who it may be relevant to
Registry conditions: Gynecologic Cancer, Skin Cancer, Head and Neck Cancer, Sarcoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium, France, Germany, Italy, Poland +2
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Radiation Stereotactic body radiotherapy
    Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size \& location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
  • Radiation Palliative RT
    Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation

Primary outcome measures

  • Overall survival [Time frame: 7.5 years from first patient in]
Secondary outcome measures (8)
  • Progression-free survival [Time frame: 9 years from first patient in]
  • Disease-specific survival [Time frame: 9 years from first patient in]
  • Time to disease progression [Time frame: 9 years from first patient in]
  • Time to development of new metastatic lesions [Time frame: 9 years from first patient in]
  • Time to development of polymetastatic disease [Time frame: 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 [Time frame: 9 years from first patient in]
  • Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires [Time frame: 9 years from first patient in]
  • Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires [Time frame: 9 years from first patient in]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Belgium · 3 centers
  • Institut Jules Bordet — Anderlecht
  • Universitair Ziekenhuis Gent — Ghent
  • Gasthuiszusters Antwerpen - Sint-Augustinus — Wilrijk
France · 2 centers
  • Centre Oscar Lambret — Lille
  • Gustave Roussy — Villejuif
Poland · 2 centers
  • Medical University Of Gdansk — Gdansk
  • Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research I — Warsaw
Switzerland · 2 centers
  • Inselspital — Bern
  • UniversitaetsSpital Zurich — Zurich
United Kingdom · 2 centers
  • University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical C — Birmingham
  • Royal Marsden Hospital - site: Chelsea, London — London
Germany · 1 center
  • Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - Univers — Hamburg
Italy · 1 center
  • Istituto Europeo di Oncologia — Milan

Identifiers

NCT: NCT04498767 · EORTC 1945

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗