An interventional study of Intra-arterial chemoinfusion of breast cancer in Breast Cancer, sponsored by Assiut University. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.
Breast cancer is one of the most common malignancies affecting women worldwide, and its incidence has seen a steady increase over the years with the involvement of women at a much younger age, which poses a serious health threat to women and has a staggering global impact.
Lymph node and hematogenous metastasis occurs at the early stage of breast cancer and is the principal cause of mortality of breast cancer patients.
Surgical resection is the most effective method for the treatment of breast cancer, and neoadjuvant chemotherapy reduces the risk of disease recurrence and death in women who have operable breast cancer.
For patients with inoperable breast cancer, neoadjuvant chemotherapy reduces tumor bulk and tumor stage, thereby increasing the chance of surgical resection and reducing postoperative tumor recurrence and metastasis.
Local or regional chemotherapy is an alternative for reducing metastatic lesions and increasing patient survival .Intra-arterial infusion chemotherapy (chemoinfusion), a form of regional chemotherapy, has been used in the treatment of gastrointestinal tumors, liver cancer, and pancreatic cancer.
In the present prospective study, we will analyze the outcome of image-guided delivery of intra-arterially infused chemotherapeutic drugs for patients with breast cancer in III, IV stages.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 50 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Tumors are staged according to the criteria of the Union for International Cancer Control (UICC). Tumor volume was determined by mammography or magnetic resonance imaging (MRI). Patients will be cannulated via the femoral artery. Then, a 4F fixed-curve catheter (Cobra catheter, Cook Corporation, Bloomington) was advanced to the ipsilateral subclavian artery. Digital subtraction angiography (DSA) was performed to determine tumor arterial blood supply. Super selection of the internal mammary artery done by micro-catheter. Chemo-infusion was decided by the major feeding artery. The intra-arterial chemoinfusion regimen consisted of docetaxel 75 mg/m2 and epirubicin 50 mg/m2 in 200 mL of normal saline and 5% glucose; the drugs were slowly infused via the catheter over at least 15 minutes. Intraarterial infusion was performed once every 3 weeks on average.
Procedure: Intra-arterial chemoinfusion of breast cancer
Patients will be cannulated via the femoral artery. Then, a 4F fixed-curve catheter (Cobra catheter, Cook Corporation, Bloomington) was advanced to the ipsilateral subclavian artery. Digital subtraction angiography (DSA) was performed to determine tumor arterial blood supply. Super selection of the internal mammary artery done by micro-catheter. Chemo-infusion was decided by the major feeding artery. The intra-arterial chemoinfusion regimen consisted of docetaxel 75 mg/m2 and epirubicin 50 mg/m2 in 200 mL of normal saline and 5% glucose; the drugs were slowly infused via the catheter over at least 15 minutes. Intraarterial infusion was performed once every 3 weeks on average.
Lesion size after chemotherapy
Patient will be evaluated 3 weeks after the second intra-arterial chemo infusion. If the primary lesion and the involved lymph nodes shrunken markedly in volume and skin and muscle involvement improved noticeably, patients were assigned to undergo surgical resection
Time frame: 3 weeks
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
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Assiut University