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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||196 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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…)
- 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
- 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.
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
|Contact: Naïma Bonnet, PhD||+33(0)1 85 34 33 firstname.lastname@example.org|
|Contact: Daniel Couch, PhDemail@example.com|
|Contact: Adeline PETIT, MD|
|Centre Leonard de Vinci||Active, not recruiting|
|Centre de Cancérologie du Grand Montpellier||Recruiting|
|Contact: Beatrice LAFFORGUE, MD|
|Centre Henri Becquerel||Recruiting|
|Contact: Sébastien THUREAU, MD|
|Principal Investigator:||Sebastien Thureau, MD||Centre Henri Becquerel|
|Principal Investigator:||Jean-Christophe Faivre, MD||Institut de Cancérologie de Lorraine - Alexis Vautrin|