Oncology Clinical Trials

Breast Research Studies
 
Alliance A011401:  (BWELL) Randomized Phase III trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese women with Early Stage Breast Cancer
 
A supervised weight loss intervention plus health education materials vs health education materials alone upon invasive disease free survival (iDFS) in overweight (BMI 27-29.9 kg/m2) and obese (BMI ≥30kg/m2) women diagnosed with HER-2 negative, stage II and III breast cancer.
 
NRG BR003:  A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer
 
To determine whether the addition of carboplatin to an adjuvant chemotherapy regimen of AC followed by Taxol will improve the invasive disease-free survival (IDFS) compared to AC followed by Taxol when administered to patients with operable node-positive or high-risk node-negative triple-negative breast cancer.
 
Breast CyberKnife (Registry):  A Pilot Study of Partial Breast CyberKnife Radiosurgery for Postmenopausal Women (≥50 y/o) with DCIS or Stage I Breast Cancer
 
Observation registry trial will evaluate the efficacy and toxicity of Stereotactic Accelerated Partial Breast Irradiation delivered with the CyberKnife in early stage breast cancer.  We will also evaluate oncologic and cosmetic outcomes.
 
Head and Neck Research Studies
Identification of Risk Factors for Head and Neck Cancers for Patients who are Treated at Saint Peter’s University Hospital
To learn more about risk factors for head and neck cancers for our patients who are treated at SPUH.  The results from this study will allow us to identify the risk factors for head and neck cancers in our diverse patient population and to implement strategies to reduce those risks in our community.

Pharyngeal Constrictor StudyDysphagia after Radiation to the Pharyngeal constrictor Muscles Measured in Terms of Quality of Life
 
The purpose of this study is to determine acceptable doses of radiation to the pharyngeal constrictor muscles during irradiation for head and neck malignancies.  The aim is to quantify these doses in relation to swallowing related Quality of Life as reported by patients. 

Lung Cancer Research Studies
CKR vs. EBRT – Lung Cancer Registry Study:  Cyberknife Radiosurgery vs. External Beam Radiation Therapy
The purpose of this registry study is to track outcomes for men and women with lung cancer who are being treated with either CyberKnife® radiosurgery (CKR) or external beam radiation therapy (EBRT) at Saint Peter’s University Hospital / Radiation Oncology.
 
A Prospective Trial of Immunotherapy and Stereotactic Body Radiotherapy for the Treatment of Metastatic Lung Cancer Testing the Safety and Effects of Radiation combined with Immunotherapy in the treatment of advanced lung cancer
 
This study seeks to combine immunotherapy which has been shown to be superior to chemotherapy in metastatic lung cancer with stereotactic body radiation therapy (SBRT). It has been demonstrated in small studies that SBRT can work in concert with immunotherapy to induce robust immune response and increased anti-cancer effectiveness. Data regarding the safety and efficacy of combined SBRT to multiple lesions with sequential immunotherapy is limited. There is no compelling evidence that toxicity is increased when SBRT is delivered prior to immunotherapy in the treatment of metastatic lung cancer. Immunotherapy will be delivered and supervised per standard of care by the treating medical oncologist. Risks and side effects associated with immunotherapy are known and will be discussed in standard fashion by the treating physician. In this study, radiation therapy delivery is being investigated and immunotherapy is considered standard of care.
 
Rectal Research Study
Alliance/N1048: A Phase II/III Trial of Neoadjuvant FOXFOX with Selective Use of combined Modality
Chemoradiation Vs Preoperative Combined Modality Chemoradiation for Locally Advanced Rectal
Cancer Patients Undergoing Low Anterior Resection with Total Mesorectal Excision
 
To compare the effects of the standard treatment of chemotherapy (5-fluorouracil/capecitabine) and radiation to chemotherapy using a combination regimen known as FOLFOX, and selective use of the standard treatment, depending on response to the FOLFOX.
 
**Connect MDS/AML Disease Registry: The Myelodysplastic Syndromes and Acute Myeloid Leukemia Disease Registry
 
The Connect® MDS and AML Disease Registry is a US prospective, longitudinal, multi-center observational cohort study of patients with newly diagnosed MDS, ICUS or AML within 60 days prior to the date of ICF signature confirmed by the Central Eligibility Review of clinical diagnostic reports including, but not limited to, BM biopsies/aspirates reports, cytogenetic report, peripheral blood laboratory results (including the percentage of blasts, if available), and any other laboratory results or reports that led to the diagnosis of MDS, ICUS or AML. Data entry into the Registry electronic data capture (EDC) system will be at screening, enrollment (i.e.,baseline) and then approximately on a quarterly basis through the duration of the patient’s
participation in the Registry.

**Inform CLL:  A Disease Registry for Patients with Chronic Lymphocytic Leukemia
 
The study is designed as a multicenter, prospective, observational registry of CLL patients who are initiating approved oral kinase inhibitors or other approved anti-CLL therapies/regimens. The study will characterize treatment patterns and their association with patient characteristics, healthcare resource utilization, and clinical outcomes, as well as patient-reported outcome (PRO) measures. The study will not provide or recommend any treatment; all decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices. Patients who are prescribed novel therapies including approved oral kinase inhibitors (e.g., approved inhibitors of BTK or PI3K) or other approved anti-CLL therapies/regimens by their physician will be invited to participate in the registry after the treatment decision has been made.
 
Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma. (MAGNIFY)
 
A Phase 3B Randomized Study of Lenalidomide (CC-5013) Plus Rituximab Maintenance Therapy Followed by Lenalidomide Single-Agent Maintenance Versus Rituximab in Subjects With Relapsed/Refractory Follicular, Marginal Zone, or Mantle Cell Lymphoma
 
TheraSphere:   A Humanitarian Device Exemption use Protocol of TheraSphere® For Treatment of Unresectable Primary or Unresectable Secondary Liver Cancer
 
 
 
 
CONTACTS:
Gopal Desai, M.D.
Chairman, Radiation Oncology
Telephone: (732) 745-8590
Sameer Desai, M.D.
Telephone: (732) 246-4882
Kathy Covert, APN-BC, MSN, AOCN
Oncology Nurse
Telephone: (732) 745-8600 ext. 6163
Susan Maney
Research Coordinator
Telephone: (732) 745-8600 ext. 8295
Charlene Drost, RN
Research Nurse – Office of Research
732-745-8600 X6136
 

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