Informations générales (source: ClinicalTrials.gov)
Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment
Interventional
Phase 3
Gustave Roussy, Cancer Campus, Grand Paris (Voir sur ClinicalTrials)
février 2014
février 2026
14 septembre 2025
The previous reported phase I study allows us to prospectively define the optimal total
dose in different metastatic locations (88). However, several questions are still
unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT)
in oligometastatic disease. Indeed, there are two different oligometastatic states: "de
novo", i.e. occurring at first metastatic presentation without any previous systemic
therapy; and "secondary", defined as residual disease after systemic treatment.
The investigators wish to prospectively study the role of metastases SBRT with curative
intent in de novo oligometastatic disease.
This clinical trial would be the first randomized study studying SBRT at onset of the
metastatic disease. If this trial shows a PFS improvement, it will definitively change
the standard of treatment and it will highlight SBRT as a key treatment of metastatic
disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton
hypothesis (92).
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT GUSTAVE ROUSSY | Sofia RIVERA | 16/04/2024 07:02:22 | Contacter | ||
Critères
Femme
Inclusion Criteria:
1. Biopsy proven breast cancer stage IV AJCC TNM
2. Age >18 years
3. WHO status</=2
4. Hormonal receptors positive breast cancer (IHC)
5. The primary tumor was treated or will be treated with curative intent (surgery and
/or radiotherapy)
6. No prior treatment for metastatic relapse. It will be accepted patients which would
have begun a treatment in the case where:
1. Hormonotherapy </= 1 month
2. Chemotherapy </= 1 cycle
The treatment must be stopped after signature of the consent form.
7. a. Metastatic lesions out of previous radiation field;
b. Equal or less than 5 metastatic lesions (measurable or not);
c. In case of measurable lesions, each </=10 cm or </=500 mL
8. For liver mets:
1. adequate liver function (liver enzyme <3N, bilirubin <30mg/dl, albumin
>2.5g/dl)
2. no underlying cirrhosis or hepatitis
3. liver metastase size </=7cm diameter
4. not adjacent to stomach or small bowel
9. For abdominal mets:
a. adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min
10. Absence of any psychological, familial, sociological or geographical condition with
a potential to hamper compliance with the study protocol and follow-up schedule
11. Life expectancy > 3 months
12. Affiliated to Health Insurance regimen
13. Written and signed consent form
Non-inclusion Criteria:
1. Triple negative breast cancer
2. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy,
targeted therapies, radionuclide)
3. Brain metastases
4. In spinal cord mets:
1. More than 3 consecutive and contiguous spinal segments involved by tumor
2. Neurological examination prior randomization > 1 week
3. Inability to tolerate treatment (unable to lie flat)
4. Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
5. Significant or progressive neurological deficit
6. More than 25% spinal canal compromise
7. Malignant epidural spinal cord compression or cauda equina syndrome
8. Spine instability or neurological deficit resulting from bony compression of
neural structures
5. Scleroderma or connective tissue disease as a contraindication to radiotherapy
6. Pregnancy or breast feeding period
1. Biopsy proven breast cancer stage IV AJCC TNM
2. Age >18 years
3. WHO status</=2
4. Hormonal receptors positive breast cancer (IHC)
5. The primary tumor was treated or will be treated with curative intent (surgery and
/or radiotherapy)
6. No prior treatment for metastatic relapse. It will be accepted patients which would
have begun a treatment in the case where:
1. Hormonotherapy </= 1 month
2. Chemotherapy </= 1 cycle
The treatment must be stopped after signature of the consent form.
7. a. Metastatic lesions out of previous radiation field;
b. Equal or less than 5 metastatic lesions (measurable or not);
c. In case of measurable lesions, each </=10 cm or </=500 mL
8. For liver mets:
1. adequate liver function (liver enzyme <3N, bilirubin <30mg/dl, albumin
>2.5g/dl)
2. no underlying cirrhosis or hepatitis
3. liver metastase size </=7cm diameter
4. not adjacent to stomach or small bowel
9. For abdominal mets:
a. adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min
10. Absence of any psychological, familial, sociological or geographical condition with
a potential to hamper compliance with the study protocol and follow-up schedule
11. Life expectancy > 3 months
12. Affiliated to Health Insurance regimen
13. Written and signed consent form
Non-inclusion Criteria:
1. Triple negative breast cancer
2. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy,
targeted therapies, radionuclide)
3. Brain metastases
4. In spinal cord mets:
1. More than 3 consecutive and contiguous spinal segments involved by tumor
2. Neurological examination prior randomization > 1 week
3. Inability to tolerate treatment (unable to lie flat)
4. Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
5. Significant or progressive neurological deficit
6. More than 25% spinal canal compromise
7. Malignant epidural spinal cord compression or cauda equina syndrome
8. Spine instability or neurological deficit resulting from bony compression of
neural structures
5. Scleroderma or connective tissue disease as a contraindication to radiotherapy
6. Pregnancy or breast feeding period