Gynecologic CancerOligoRARENCT04498767
Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
A study testing Stereotactic body radiotherapy and Palliative RT in people with Gynecologic Cancer and Skin Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 13 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gynecologic Cancer, Skin Cancer, Head and Neck Cancer
- What is being tested?
- Stereotactic body radiotherapy and Palliative RT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 13 sitesin 7 countries
- Study dates
- 10 Jun 2021to 1 Feb 2030
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
13 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 7 countries
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Anderlecht, 1070
- Recruiting
Universitair Ziekenhuis Gent
Ghent, 9000
- Recruiting
Gasthuiszusters Antwerpen - Sint-Augustinus
Wilrijk, 2610
France2 sites, 2 recruiting
- Recruiting
Centre Oscar Lambret
Lille, 59020
- Recruiting
Gustave Roussy
Villejuif, 94805
Poland2 sites, 2 recruiting
- Recruiting
Medical University Of Gdansk
Gdansk, Mariana Smoluchowskiego 17, PL 80-214
- Recruiting
Maria Sklodowska-Curie Memorial Cancer Centre - Maria Sklodowska-Curie National Research Institute of Oncology
Warsaw, PL 02 781
Switzerland2 sites, 2 recruiting
- Recruiting
Inselspital
Bern, 3010
- Recruiting
UniversitaetsSpital Zurich
Zurich, 8091
United Kingdom2 sites, 2 recruiting
- Recruiting
University Hospitals Birmingham NHS Foundation Trust (UHB) - UHB-Queen Elisabeth Medical Centre
Birmingham, B15 2TH
- Recruiting
Royal Marsden Hospital - site: Chelsea, London
London, SW3 6JJ
Germany1 site, 1 recruiting
- Recruiting
Universitaets Krankenhaus Eppendorf - Universitaetsklinikum Hamburg-Eppendorf KE - University Cancer Center
Hamburg, Martinistrasse 52, DE 20246
About this study
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
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.
- Conditions
- Gynecologic Cancer, Skin Cancer, Head and Neck Cancer, Sarcoma, Renal Cancer, Bladder Cancer
- Being tested
- Stereotactic body radiotherapy, Palliative RT
- Keywords
- oligometastatic cancer, Stereotactic body radiotherapy, SBRT
- Medical subject headings
- Skin Neoplasms, Head and Neck Neoplasms, Sarcoma, Kidney Neoplasms, Urinary Bladder Neoplasms, Pancreatic Neoplasms, Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapyRadiation
Also called SBRT
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.
Palliative RTRadiation
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 to a new brain metastases when all disease is controlled on systemic therapy).
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Standard of Care + palliative RT | Active comparator | 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 to a new brain metastases when all disease is controlled on systemic therapy).
Systemic therapy will be pre-specified based on the standard of care approach for that patient, and it may include cytotoxic, targeted, hormonal, or immunotherapy. Receives: Radiation: Palliative RT |
| Arm 2: Standard of Care + SBRT | Experimental | The experimental arm consists of SBRT (and standard of care systemic therapy). 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.
Patients treated with prior or concomitant systemic therapy are eligible for this study. Use of chemotherapy regimens, targeted therapy or immunotherapy containing potent enhancers of radiation damage (e.g. gemcitabine, doxorubicin) can be postponed or interrupted for a duration of one month after radiation. Receives: Radiation: Stereotactic body radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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.
Measured: 7.5 years from first patient in
Secondary outcomes (8)
Progression-free survival
Measured: 9 years from first patient in
Disease-specific survival
Measured: 9 years from first patient in
Time to disease progression
Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.
Measured: 9 years from first patient in
Time to development of new metastatic lesions
Time to development of new metastatic lesions is the time interval from the date of randomization to the date of first occurrence of any of the following events:
- Development new metastatic lesions,
- Cancer-related death.
Measured: 9 years from first patient in
Time to development of polymetastatic disease
Time to development of polymetastatic disease is the time interval from the date of randomization to the date of first occurrence of any of the following events:
- Presence of more than 5 metastases at a specific timepoint during follow-up,
- Development of metastases that preclude treatment with SBRT (e.g. due to large size or locating in previously irradiated region where re-irradiation is not possible),
- Cancer-related death.
Measured: 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
Measured: 9 years from first patient in
Health-related quality of life evaluated using self-administered EORTC QLQ-C30 questionnaires
Measured: 9 years from first patient in
Health-related quality of life evaluated using self-administered EQ-5D-5L questionnaires
Measured: 9 years from first patient in
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2020
- Study start10 Jun 2021
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- Research network
- Collaborators
- Anticancer Fund, Belgium, Rising Tide Foundation
- Responsible party
- Sponsor
- Investigators
- Matthias Guckenberger, Principal investigator, University of ZurichPiet Ost, Principal investigator, Gasthuiszusters Antwerpen - Sint-Augustinus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498767
- Sponsor's protocol ID
- EORTC 1945
- Acronym
- OligoRARE
- Status last verified
- Aug 2024
- First submitted
- 30 Jul 2020
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No