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 5 metastases) in solid tumor patients is able to improve the survival without progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
168
SBRT will be added to systemic (standard) treatment of bone metastases.
ICO - Site Paul Papin
Angers, France
Centre Marie Curie
Arras, France
Hôpital Privé Les Bonnettes
Arras, France
Institut Sainte Catherine
Avignon, France
Centre Pierre Curie
Beuvry, France
Clinique Ambroise Pare
Beuvry, France
Clinique Tivoli Ducos
Bordeaux, France
Institut Bergonié
Bordeaux, France
Hôpital Métropole Savoie
Chambéry, France
Pôle Leonard de Vinci
Chambray-lès-Tours, France
...and 18 more locations
Progression Free Survival
To evaluate the impact of SBRT on Progression-Free Survival (PFS) at 1 year according to RECIST 1.1 and PERCIST 1.0 Criteria
Time frame: 1 year
PFS at 2 and 3 years
Progression-Free Survival (PFS) at 2 and 3 years will be evaluated according to RECIST 1.1 and PERCIST
Time frame: 2 years and 3 years after treatment
Bone progression free survival at 1, 2 and 3 years
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
Time frame: 1, 2 and 3 years after treatment
Local control at 1, 2 and 3 years
Local control will be evaluated at 1, 2 and 3 years according to RECIST Criteria 1.1 and PERCIST
Time frame: 1, 2 and 3 years after treatment
Cancer-specific survival
The length of time from the start of treatment for the disease until the death identified as being due to the specified cancer.
Time frame: 1, 2 and 3 years after treatment
Overall survival
The length of time from the start of treatment for the disease until patients are still alive.
Time frame: 1, 2 and 3 years after treatment
SBRT toxicities
according CTCAE 4.0 scale
Time frame: 1, 2 and 3 years after treatment
Patient's Quality of life
self-administered questionnaire
Time frame: at baseline, 6 weeks after randomization, and 3 months, 6 months and 1, 2 and 3 years after treatment
Pain score
according to Numeric Scale related to pain medication
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
Cost utility
QALYs (Quality-Adjusted Life Years) and ICERs (Incremental Cost-Effectiveness Ratios) calculation based on EQ-5D-3L questionnaire.
Time frame: 6 weeks after randomization
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