| Titre |
A Phase IIR/III Trial of Standard of Care Therapy With or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer |
| Protocole ID |
NRG-BR002 |
| ClinicalTrials.gov ID |
NCT02364557 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Tarek Hijal
|
| Coordonnateur(trice) |
Tatiana Carvalho
514-934-1934 poste 43698
|
| Statut |
![]() Fermé |
| Date d'activation |
04-02-2016 |
| Critètes d'éligibilité |
- Pathologically confirmed metastatic breast cancer within 270 days prior to registration
- Known estrogen, progesterone, and HER2 status of either primary tumor or metastasis
- =< 2 metastases seen on standard imaging within 30 days prior to registration
- Controlled primary tumor site defined as >= 3 months (90 days) recurrence-free interval since completion of definitive surgical management
-
All known disease amenable to metastasis-directed therapy with either SBRT or resection
- NOTE: Symptomatic bone metastasis are allowed if ablative therapy can be delivered
- NOTE: Sites for possible surgical excision include lung, liver, adrenal gland, bone, small intestine, large intestine, ovary, and amenable nodal disease sites
- NOTE: Surgical stabilization is allowed for a metastasis if it is followed by conventionally fractionated external beam radiotherapy
- Maximum diameter of individual metastasis in any dimension =< 5 cm
-
Metastases must be > 5 cm away from each other (defined as Edge to Edge of tumor)
- NOTE: If metastases are =< 5 cm away from each other, consider enrollment in NRG-BR001
- First-line standard systemic therapy (chemotherapy, anti-endocrine therapy, anti-HER2 or other standard targeted therapy) for metastatic breast cancer not to have exceeded a duration of 6 months at the time of registration
-
Appropriate stage for study entry based on the following diagnostic workup:
- History/physical examination within 30 days prior to registration
- Computed tomography (CT) scans of the chest, abdomen, and pelvis with radionuclide bone scan OR whole body positron emission tomography (PET)/CT within 30 days prior to study registration
- Zubrod performance status =< 2 within 30 days prior to registration
- Absolute neutrophil count (ANC) >= 500 cells/mm^3
- Platelets >= 50,000 cells/mm^3
- Hemoglobin >= 8.0 g/dl (note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 8.0 g/dl is acceptable)
- For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration
- The patient must provide study-specific informed consent prior to study entry
|
| Critètes d'exclusion |
- Pathologic evidence of local/regional breast tumor recurrence
- Co-existing or prior invasive malignancy (except non-melanomatous skin cancer), unless disease free for a minimum of 3 years
-
Metastases with indistinct borders making targeting not feasible
- NOTE: A potential issue with bone metastases is that they often are not discrete; since many patients on this protocol will have bone metastases, this will be an important issue; theoretically, Houndsfield units might provide an appropriate measure; however, a sclerotic lesion against dense cortical bone will not have a sharp demarcation based on Houndsfield units (HU); therefore, we acknowledge that such determinations will pose a challenge and thus the physician's judgment will be required
- Prior palliative radiation treatment for metastatic disease
-
Metastases located within 3 cm of the previously irradiated structures:
- Spinal cord previously irradiated to > 40 Gy
- Brachial plexus previously irradiated to > 50 Gy
- Small intestine, large intestine, or stomach previously irradiated to > 45 Gy
- Brainstem previously irradiated to > 50 Gy
- Lung previously irradiated with prior V20Gy > 30%
- Brain metastases
- Exudative, bloody, or cytological proven malignant effusions
-
Severe, active co-morbidity defined as follows:
- Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
- Transmural myocardial infarction within the last 6 months
- Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
- Pregnancy; lactating females must cease expression of milk prior to signing consent to be eligible
- Human immunodeficiency virus (HIV) positive with cluster of differentiation (CD)4 count < 200 cells/microliter; note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count >= 200 cells/microliter within 30 days prior to registration; note also that HIV testing is not required for eligibility for this protocol
|
Groupe d'étude en oncologie du Québec