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Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases (STEREO-OS)

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ClinicalTrials.gov Identifier: NCT03143322
Recruitment Status : Recruiting
First Posted : May 8, 2017
Last Update Posted : October 4, 2018
Sponsor:
Collaborator:
National Cancer Institute, France
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

Bone metastases occur frequently during the evolution of solid tumors, either isolated or associated with visceral metastases. The incidence varies between 20 and 85% depending on the primary cancer. Breast, prostate, and lung cancers are responsible for 70% of bone metastases. Cancer with bone metastases compared to other metastatic sites is considered as associated with a better prognosis, particularly for breast and prostate cancer. Bone metastases may be present at diagnosis (synchronous metastasis) or appear at a later time (metachronous metastasis).

The concept of "oligometastases" was proposed in patients with about 3 up to 5 metastases (without restriction on the primary site) and associated with an intermediate prognosis. It was hypothesized that local treatment with curative intent, aiming at the few metastatic sites, would yield long-term survival probabilities, along with systemic therapies.

Long-term survivors have been reported after curative-intent treatment of metastasis in sarcoma and colorectal cancers with liver or lung metastasis. We chose to focus on bone metastasis because of their high incidence, their impact on the patient's quality of life and autonomy, and their accessibility to potentially curative radiotherapy.

The systemic treatment of metastatic cancer includes hormonal therapy (breast and prostate cancer), biologically-targeted drugs and chemotherapy (all cancers).

Stereotactic radiotherapy is a highly accurate technique was initially developed for performing the radiosurgery of brain tumors in patients for whom it was deemed be too difficult to proceed to classical excision surgery. In this process, a high total dose of radiation is delivered in a single fraction to a well-defined intra-cranial target. The concept of radiotherapy in stereotactic conditions was extended to one or several fractions delivered to small volumes primary tumors/ metastases in extra-cranial sites (Stereotactic Body RadioTherapy [SBRT]). At present, high control rates have been achieved for lung metastases. Similarly, very high local control rates have been reported in bone metastases after stereotactic radiotherapy.

In this protocol, our purpose is to demonstrate, via a randomized phase III trial, that high doses of radiotherapy, delivered in stereotactic conditions to the bone metastases (between 1 and 3 metastases) in solid tumor patients is able to improve the survival without progression.


Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Metastatic Lung Cancer Metastatic Prostate Cancer Bone Metastases Radiation: SBRT Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 196 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extracranial Stereotactic Body Radiation Therapy (SBRT) Added to Standard Treatment Versus Standard Treatment Alone in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases
Actual Study Start Date : January 1, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Systemic treatment + SBRT
Systemic treatment and SBRT to the bone metastases. Two SBRT schemes are allowed: 9 Gy x 3 fractions or 7 Gy x 5 fractions for axial and appendicular bones metastases. The choice is at the discretion of the investigator.
Radiation: SBRT
SBRT will be added to systemic (standard) treatment of bone metastases.

No Intervention: Systemic treatment
Palliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…)



Primary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 1 year ]
    To evaluate the impact of SBRT on Progression-Free Survival (PFS) at 1 year according to RECIST 1.1 and PERCIST 1.0 Criteria


Secondary Outcome Measures :
  1. PFS at 2 and 3 years [ Time Frame: 2 years and 3 years after treatment ]
    Progression-Free Survival (PFS) at 2 and 3 years will be evaluated according to RECIST 1.1 and PERCIST

  2. Bone progression free survival at 1, 2 and 3 years [ Time Frame: 1, 2 and 3 years after treatment ]
    Distant bone progression at 2 and 3 years will be evaluated according to RECIST Criteria 1.1 and at 1 year according to RECIST Criteria 1.1 and PERCIST

  3. Local control at 1, 2 and 3 years [ Time Frame: 1, 2 and 3 years after treatment ]
    Local control will be evaluated at 1, 2 and 3 years according to RECIST Criteria 1.1 and PERCIST

  4. Cancer-specific survival [ Time Frame: 1, 2 and 3 years after treatment ]
  5. Overall survival [ Time Frame: 1, 2 and 3 years after treatment ]
  6. SBRT toxicities [ Time Frame: 1, 2 and 3 years after treatment ]
    according CTCAE 4.0 scale

  7. Patient's Quality of life [ Time Frame: at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment ]
    self-administered questionnaire

  8. Pain score [ Time Frame: at baseline, once a week during 2 weeks and 6 weeks after randomization, and at 3 months, 6 months and 1, 2 and 3 years after treatment ]
    according to Numeric Scale related to pain medication

  9. Cost utility [ Time Frame: 6 weeks after randomization ]
    QALYs (Quality-Adjusted Life Years) and ICERs (Incremental Cost-Effectiveness Ratios) calculation based on EQ-5D-3L questionnaire.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients older than 18 years and younger than 75 years
  2. Good general condition: WHO performance status ≤1
  3. Patients with histological proof of breast, non-small cell lung, or prostate cancer
  4. Absence of co-morbidity contra-indicating radio-chemotherapy or surgery
  5. Primary tumor accessible to curative-intent treatment (surgery, chemoradiation…) for patients with synchronous metastases
  6. Patients with between 1 and 3 synchronous or metachronous bone metastases as defined by NaF-PET and spinal MRI (if necessary)
  7. Bones metastases treatable by SBRT
  8. Women of childbearing potential and male patients must agree to use adequate contraception for the duration of study participation and up to 3 months following completion of therapy
  9. Patients who have received the information sheet, dated and signed the informed consent form
  10. Affiliated to the social security system

Exclusion Criteria:

  1. Visceral metastases as defined by FDG-PET (or F-Choline-PET for prostate cancer) and cerebral CT or MRI performed within six weeks before SBRT
  2. Previous systemic therapy for metastasis for patients with metachronous metastasis. Prostate cancer patients remain eligible if hormonal treatment was initiated before enrollment
  3. All bone metastasis requiring surgical treatment (spinal cord compression, fracture…)
  4. More than 3 bone metastases as defined by NaF-PET and spinal MRI (if spinal bone metastases on NaF-PET)
  5. Previous cancer within the 5 years before inclusion (except basal cell carcinoma of the skin, in situ carcinoma of the uterine cervix)
  6. Previous radiotherapy on bone metastasis (e.g: antalgic radiotherapy)
  7. Patient enrolled in another therapeutic trial
  8. Pregnant women or breast feeding mothers,
  9. Hypersensitivity to the active substance (FDG and NaF or F-Choline for prostate cancer) or to any of the excipients
  10. Contraindication to MRI
  11. Patients deprived of liberty or placed under the authority of a tutor. Patients with 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 registration in the trial. Patients unable to understand the purpose of the study (language, etc.).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03143322


Contacts
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Contact: Naïma Bonnet, PhD +33(0)1 85 34 33 74 n-bonnet@unicancer.fr
Contact: Daniel Couch, PhD d-couch@unicancer.fr

Locations
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France
Institut Bergonié Recruiting
Bordeaux, France
Contact: Adeline PETIT, MD         
Centre Leonard de Vinci Active, not recruiting
Chambray-lès-Tours, France
Centre de Cancérologie du Grand Montpellier Recruiting
Montpellier, France
Contact: Beatrice LAFFORGUE, MD         
Centre Henri Becquerel Recruiting
Rouen, France
Contact: Sébastien THUREAU, MD         
Sponsors and Collaborators
UNICANCER
National Cancer Institute, France
Investigators
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Principal Investigator: Sebastien Thureau, MD Centre Henri Becquerel
Principal Investigator: Jean-Christophe Faivre, MD Institut de Cancérologie de Lorraine - Alexis Vautrin

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03143322     History of Changes
Other Study ID Numbers: UC-0107/1603
First Posted: May 8, 2017    Key Record Dates
Last Update Posted: October 4, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by UNICANCER:
Bone-only metastases
solid tumors
SBRT

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Lung Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases