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| ID | Type | Description | Link |
|---|---|---|---|
| HM-213 | Other Identifier | Fox Chase Cancer Center |
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This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection.
This is an open-label, single institution study evaluating the efficacy of intravenous iron sucrose monotherapy in patients with thoracic, breast, GU and GI malignancies undergoing neoadjuvant chemotherapy with the goal of undergoing surgical resection. The concomitant use of radiation and immunotherapy as part of the neoadjuvant protocol is allowed in this protocol. The study is designed to evaluate the efficacy of iron infusions in reducing blood transfusion frequency and improving hemoglobin levels prior to surgical intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venofer treatment | Experimental | Venofer (iron-sucrose) 200mg (5 days) every week administered as an IV infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venofer | Drug | Intravenous iron will be administered as five doses of 200 mg of iron sucrose (Venofer, American Regent, Shirley, NJ) in 100 ml normal saline over a duration of 15 minutes to 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline to highest Hgb value | To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia by improving the hemoglobin of patients undergoing neoadjuvant chemotherapy. Mean change from baseline to highest Hgb value observed six weeks after last iron infusion, before day of surgery. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of transfusions during neo-adjuvant period | To evaluate the efficacy of iron infusions in improving chemotherapy-induced anemia and minimizing red blood cell transfusions in patients undergoing neoadjuvant chemotherapy. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ryan Romasko | Contact | 2678388380 | ryan.romasko@fccc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Iberia Sosa, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Recruiting | Philadelphia | Pennsylvania | 19111 | United States |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |