Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
UNICANCER
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients older than 18 years and younger than 75 years
2. Good general condition: WHO performance status ≤ 2
3. Patients with histological proof of breast, non-small cell lung, or prostate cancer Note: Histological proof can be done on the primitive tumour and/or adenopathy and/or metastatic site.
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 5 synchronous or metachronous bone metastases as defined by NaF-PET or conventional SPECT-CT scan and spinal MRI (if necessary) within 6 weeks before randomization)
7. Bones metastases treatable by SBRT
8. Primary cancer considered to be controlled or accessible to curative-intent treatment (surgery, chemoradiation…) in case of locoregional recurrence for metachronous bone oligo-metastatic disease
9. 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
10. Patients who have received the information sheet, dated and signed the informed consent form
11. Affiliated to the social security system
3. All bone metastasis requiring surgical treatment (spinal cord compression, fracture…)
4. More than 5 bone metastases as defined by NaF-PET or conventional SPECT-CT scan 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 or PSMA for prostate cancer) or to any of the excipients
10. Contraindication to MRI (in case of spinal metastases)
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.).
You may not be if
1. Visceral metastases as defined by FDG-PET (F-Choline-PET or PSMA PET-CT for prostate cancer) and cerebral CT or MRI performed.
Clareo Health | Standard Treatment +/- SBRT in Solid Tumors Patients With Between 1 and 5 Bone-only Metastases
