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ProtocolTrial Name and Objective
041001

Accelerated, Hypofractionated Post-Mastectomy Radiation Therapy in Women with Breast Cancer: A Phase II Trial

This study is a non-randomized, single arm study of female patients with invasive carcinoma of the breast who have had (or will have) a mastectomy followed by radiation therapy. The term 'accelerated' means that a higher radiation dose per treatment will be delivered over a shorter period of time (compared to the standard). Prior studies suggest that the accelerated radiation scheme used in this study is comparable to the standard or conventional whole breast radiation. That is, the evidence points to accelerated treatments may work at least as well as the longer, standard treatments. Along with measuring the recurrence outcomes, we will be measuring treatment side effects and cosmesis (how well the study treatment plan preserves the appearance of your surgically reconstructed breast).
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040703

Significance of Single Nucleotide Polymorphisms in Breast Cancer Patients Undergoing Radiation Therapy

In a cohort of approximately 250 women, diagnosed with breast cancer and treated with breast conserving surgery or mastectomy and radiation we will evaluate the frequency of this polymorphism (SNP309). We will correlate the polymorphism status with other clinical, pathologic and genetic information we have on these 250 women, including but not limited to stage, age of onset of disease, receptor status, her2 status, and the status of BRCA1 and BRCA2. We will recruit additional patients with a new diagnosis of breast cancer to correlate the status of SNP309 with other clinical and pathological variables.
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031205

The Possible Role of ERCC1 in Determining Patterns of Recurrence after Chemoradiation for Lung Cancer

This study intends to characterize ERCC1 overexpression in predicting local recurrence of non-metastatic lung cancer and pancreas cancer treated with radiation therapy (RT) with or without chemotherapy. It is hypothesized that higher ERCC1 levels would allow for improved repair capacity and higher chance of local recurrence after radiation therapy
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111003

COG ACNS0831: Phase III Randomized Trial of Post-Radiation Chemotherapy in Patients with Newly Diagnosed Ependymoma Ages 1 to 21 years

1. To determine the event free survival (EFS) and overall survival (OS) of children with completely resected ependymoma treated with post-operative conformal radiation therapy (cRT) and then randomized to receive or not receive four cycles of post radiation maintenance chemotherapy with vincristine, cisplatin, etoposide and cyclophosphamide (VCEC).

2. To estimate the EFS and OS of children with incompletely resected ependymoma who are unable to achieve a complete response (CR) by a) post-operative induction chemotherapy or by b) second surgery who will then be non-randomly assigned to cRT followed by four cycles of maintenance chemotherapy (VCEC)

3. To further evaluate the EFS and OS of children with supratentorial classic ependymoma who achieve a complete resection at first or second resection or children who achieve a CR to short course induction chemotherapy following first surgery.
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031101

ECOG E6508: A Phase II Study of L-BLP25 and Bevacizumab in Unresectable Stage IIIA and IIIB Non-Squamous Non-Small Cell Lung Cancer after Definitive Chemoradiation

The primary objective is to determine the safety of combination therapy with chemoradiation, followed by consolidation, finally followed by L-BLP25 and bevacizumab for patients with non-squamous, locally advanced NSCLC.
The secondary objectives are to evaluate overall survival, toxicity, and progression-free survival for patients treated with L-BLP25 plus bevacizumab in addition to chemoradiation and consolidation therapy.
The laboratory endpoints of this study will attempt to determine the fraction of circulating dendritic cells and immature myeloid cells before, during and after maintenance treatment and to determine the ability of dendritic cells to induce an allogenic mixed lymphocyte reaction in vivo.
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091312

A safety study for MSB0010445 in combination with Stereotactic Body Radiation in advanced melanoma subjects following prior treatment with ipilimumab

The primary objective of the trial is as follows:
- To determine the maximum tolerated dose (MTD) of MSB0010445 in combination with Stereotactic Body Radiation Therapy (SBRT) in subjects with advanced melanoma
The exploratory objectives of the trial are as follows:
- To establish that MSB0010445 in combination with SBRT is clinically active through the observation of best overall response assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
- To further characterize the safety of MSB0010445 in combination with SBRT
- To characterize the immunogenicity of MSB0010445
- To characterize the pharmacokinetics (PK) of MSB0010445
- To propose that MSB0010445 in combination with SBRT is biologically active by observing modifications of the tumor microenvironment (by infiltration of CD8+ T cells and of regulatory T cell [Treg] in the tumor)
- To evaluate potential biomarkers of immune response correlated with clinical activity by analysis of tumor and peripheral blood samples
- To establish that MSB0010445 is clinically active through the observation of best overall response assessed by modified immune-related Response Evaluation Criteria in Solid Tumors (irRECIST)
- To evaluate the pharmacodynamic activity of MSB0010445 in combination with radiotherapy in peripheral blood
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