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

ConditionsGynecologic CancerSkin CancerHead and Neck CancerSarcomaRenal CancerBladder CancerUpper Urinary Tract CarcinomaPancreatic CancerHepatobiliary CancerGastric CancerSmall Bowel CancerEsophageal CancerMelanomaColon CancerOligometastasis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorEuropean Organisation for Research and Treatment of Cancer - EORTC

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.

at least 3 months since original tumour treated definitively, with no progression at primary site

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

Disqualifiers

Primary cancer of prostate, breast, lung or colorectal

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Stereotactic body radiotherapy

    Radiation

    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 RT

    Radiation

    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).

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Arm 1: Standard of Care + palliative RTActive comparator 1 intervention
Group B: Arm 2: Standard of Care + SBRTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7.5 years from first patient in

Secondary outcomes

1

Progression-free survival

Time frame
9 years from first patient in
2

Disease-specific survival

Time frame
9 years from first patient in
3

Time to disease progression

Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.

Time frame
9 years from first patient in
4

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.

Time frame
9 years from first patient in

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

European Organisation for Research and Treatment of Cancer - EORTC

Lead sponsor

Anticancer Fund, Belgium

Collaborator

Rising Tide Foundation

Collaborator

Source ClinicalTrials.gov
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