Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

Tracking Information
First Submitted Date  ICMJE April 28, 2017
First Posted Date  ICMJE May 8, 2017
Last Update Posted Date October 4, 2018
Actual Study Start Date  ICMJE January 1, 2018
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03143322 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 3, 2017)
  • 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
  • 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
  • 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
  • Cancer-specific survival [ Time Frame: 1, 2 and 3 years after treatment ]
  • Overall survival [ Time Frame: 1, 2 and 3 years after treatment ]
  • SBRT toxicities [ Time Frame: 1, 2 and 3 years after treatment ]
    according CTCAE 4.0 scale
  • 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
  • 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
  • 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.
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 Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 3 Bone-only Metastases
Official Title  ICMJE 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
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.

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
  • Metastatic Breast Cancer
  • Metastatic Lung Cancer
  • Metastatic Prostate Cancer
  • Bone Metastases
Intervention  ICMJE Radiation: SBRT
SBRT will be added to systemic (standard) treatment of bone metastases.
Study Arms  ICMJE
  • 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.
    Intervention: Radiation: SBRT
  • No Intervention: Systemic treatment
    Palliative radiotherapy on bone metastases is allowed if necessary (pain, fracture, spinal cord compression…)
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: May 3, 2017)
196
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date December 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Naïma Bonnet, PhD +33(0)1 85 34 33 74 n-bonnet@unicancer.fr
Contact: Daniel Couch, PhD d-couch@unicancer.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03143322
Other Study ID Numbers  ICMJE UC-0107/1603
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
Plan to Share IPD: Undecided
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE National Cancer Institute, France
Investigators  ICMJE
Principal Investigator: Sebastien Thureau, MD Centre Henri Becquerel
Principal Investigator: Jean-Christophe Faivre, MD Institut de Cancérologie de Lorraine - Alexis Vautrin
PRS Account UNICANCER
Verification Date October 2018

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