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

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ClinicalTrials.gov Identifier: NCT04498767
Recruitment Status : Recruiting
First Posted : August 4, 2020
Last Update Posted : June 30, 2021
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 4, 2020
Last Update Posted Date June 30, 2021
Actual Study Start Date  ICMJE June 10, 2021
Estimated Primary Completion Date August 1, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
Overall survival [ Time Frame: 7.5 years from first patient in ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 30, 2020)
  • 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 ]
    Disease-specific survival is the time interval from the date of randomization to the date of cancer-related death.
  • Time to development of new metastatic lesions [ Time Frame: 9 years from first patient in ]
    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 to development of polymetastatic disease [ Time Frame: 9 years from first patient in ]
    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.
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)
Official Title  ICMJE Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
    Other Name: SBRT
  • 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 to a new brain metastases when all disease is controlled on systemic therapy).
Study Arms  ICMJE
  • Active Comparator: Arm 1: Standard of Care + 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 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.

    Intervention: Radiation: Palliative RT
  • Experimental: Arm 2: Standard of Care + SBRT

    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.

    Intervention: Radiation: Stereotactic body radiotherapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 30, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2030
Estimated Primary Completion Date August 1, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: EORTC HQ +32 2 7744 1611 eortc@eortc.org
Listed Location Countries  ICMJE Belgium,   France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04498767
Other Study ID Numbers  ICMJE EORTC 1945
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party European Organisation for Research and Treatment of Cancer - EORTC
Study Sponsor  ICMJE European Organisation for Research and Treatment of Cancer - EORTC
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Matthias Guckenberger University of Zurich
Principal Investigator: Piet Ost Gasthuiszusters Antwerpen - Sint-Augustinus
PRS Account European Organisation for Research and Treatment of Cancer - EORTC
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP