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

  • STATUS
    Recruiting
  • End date
    Feb 1, 2030
  • participants needed
    200
  • sponsor
    European Organisation for Research and Treatment of Cancer - EORTC
Updated on 26 May 2022
systemic therapy
metastasis
brain metastases

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.

Details
Condition 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
Treatment Stereotactic body radiotherapy, Palliative RT
Clinical Study IdentifierNCT04498767
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC
Last Modified on26 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note