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ProtocolTrial Name and Objective

Salvage Therapeutic Radiation with Enzalutamide and ADT in Men with Recurrent Prostate Cancer (STREAM)

Primary Objective: to describe the 2 year progression-free survival in men with recurrent PSA-only disease after prostatectomy receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100 at 24 months.
Secondary Objectives: (1) to determine the proportion of men at 1, 2 and 3 years with a PSA of less than 0.1 ng/mL and testosterone receovery to greater than 100. (2) to describe the 3 year progression-free suvival in men receiving combined enzalutamide and standard androgen-deprivation therapy with salvage radiation therapy and who have had testosterone recovery to greater than 100. (3) to describe the biochemical (PSA) progression free survival over time. (4) to describe the PSA nadir. (5) to describe the time to testosterone recovery. (6) to describe the safety profile of combination enzalutamide, ADT, and XRT.


Selecting for Cetuximab Responders in Advanced Head and Neck SCC

The purpose of this protocol is to assess the feasibility/safety of a neoadjuvant cetuximab protocol in advanced head and neck SCC. The overall treatment strategy expressed in the protocol is to treat stage III/IV head and neck SCC patients (oropharynx, larynx, hypopharynx) with 3 weeks of neoadjuvant cetuximab, select those patients who respond (develop cetuximab related folliculitis or at least a partial response by CT recist criteria) and then treat them with concurrent external beam radiation therapy (EBRT) and cetuximab. Those patients who do not respond will receive concurrent cisplatinum and EBRT.

The primary objective of this protocol is to assess the safety of adding the three weeks of neoadjuvant cetuximab i.e., what percentage of patients' cancers will progress during those three weeks of neoadjuvant cetuximab by recist CT criteria. The hope is that the data derived from this study will lead to a large phase II or phase III trial.

In addition, this will be a unique platform to assess molecular markers, as we will obtain biopsies of tumor before and after 3 weeks of neoadjuvant cetuximab, as well as a skin biopsy before therapy. We plan to do DNA and RNA sequencing for these samples, in this manner checking for possible escape mechnisms from the EGFR pathway in response to anti-EGFR therapy, and for other molecular correlates to 2 year locoregional response.


Retrospective Comparative Analysis of Hematologic Toxicities in Patients Receiving Chemo-Radiotherapy in Rectal Cancers Versus Chemotherapy in Colon Cancers.

To quantify bone marrow toxicity after radiation therapy in rectal cancer patients compared to bone marrow toxicity without radiation therapy in colon cancer patients.


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.


Molecular and Genetic Markers in the Local-regional management of patients undergoing radiation therapy

1. To determine if molecular markers correlate with local relapse in patients undergoing radiation
2. To compare molecular factors with other clinical-pathologic factors


Cardiovascular Morbidity and Mortality after Breast Cancer Treatment

1. Purpose/Specific Objectives
The purpose of the proposed study is to characterize the impact of breast cancer related loco-regional treatment (e.g. surgery (lumpectomy & mastectomy) or radiation therapy) on cardiovascular outcomes and/or cerebrovascular disease in New Jersey.

The overall goal is to study the relationship of breast cancer loco-regional treatment (surgery or radiation therapy) related to cardiovascular and/or cerebrovascular diseases, treatment, environmental and familial factors with respect to long-term outcomes in terms of morbidity and mortality in New Jersey breast cancer patients. Use of procedures, readmissions, death and cause of death are the main outcome measures.

1.1 Primary Endpoint
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients who had radiation therapy for breast cancer (Using ICD9 codes 233, 174, and 175). We will compare left versus right breast cancer patients.
* To examine the rate of cardiovascular outcomes (Using ICD9 codes 410-414, and 420-429) between breast cancer patients (Using ICD9 codes 233, 174, and 175) who did not have radiation therapy for breast cancer.
1.2 Secondary Endpoints
* The differences between sub-groups compared to the reference group (lacking the factor(s) under consideration; i.e. a matched cohort of patients who were not treated for breast cancer) will be investigated by looking at the data longitudinally.
* Future studies may focus on systemic interrelationships between disease incidence, treatment, environmental parameters, etc., and address possible consequences of changes in breast cancer treatment over time on the incidence of cardiovascular and cerebrovascular disease morbidity and mortality after breast cancer treatment.


Radiation from Interventional Cardiovascular Procedures and Risk of Breast Cancer

Hypothesis: The primary hypotheses underlying this project are as follows: (1) Exposure to IR delivered during ICPs will lead to an increased risk of developing breast cancer in our cohort of patients and (2) As ICPs have become longer and more complex, the procedural changes over time may increase the relative risk of developing breast cancer.

Aim 1: To quantitate the exposure to IR delivered to patients in New Jersey who underwent interventional cardiovascular procedures.
Aim 1A: To calculate population based rates of low, moderate, high, and very high effective doses of IR from interventional cardiovascular procedures.
Aim 1B: To describe the specific types of interventional cardiovascular procedures among persons for whom the long-term risks of IR exposure are most relevant.

Aim 2: To quantitate the risk of developing breast cancer in patients admitted for cardiovascular disease in New Jersey who had received IR from interventional cardiovascular procedures by linking MIDAS with the NJSCR. We will compare the risk of developing breast cancer in patients exposed to IR (ICP group) and unexposed patients (non-ICP group).
Aim 2A: To link the MIDAS groups from Aim 1 to the NJSCR, and classify cohort members by breast cancer diagnosis.
Aim 2B: To longitudinally compare the IR exposed group with the matched unexposed group of patients who did not receive IR from interventional cardiovascular procedures.
Aim 2C: To estimate the risk of developing breast cancer based on rates of low, moderate, high, and very high effective doses of radiation from interventional cardiovascular procedures.

Aim 3: To determine systemic interrelationships between changes in interventional cardiovascular procedures over time on the incidence of breast cancer and associated rates of morbidity and mortality.


Project SOL - Sun Safety for Outdoor Laborers

The goal of this project is to develop and test a culturally relevant sun safety education program for the Hispanic outdoor day laborer population who work or reside in the Greater New Brunswick (New Jersey) area. Although little is known about the incidence of skin cancer among Hispanic outdoor day laborers, ultraviolet radiation (UVR) exposure is a key risk factor for both
melanoma and non-melanoma skin cancers, and outdoor day laborers spend a large amount of their work exposed to UVR. The incidence of melanoma has steadily increased among U.S. Hispanics in recent years.


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


AALL1231: A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239; IND# 58443) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy)

1 To compare EFS in patients with newly diagnosed T-ALL and T-LLy who are randomized to a modified ABFM backbone versus bortezomib plus the modified ABFM backbone.

2.To determine the safety and feasibility of modifying standard therapy for T-ALL and T-LLy based on the results of UKALL 2003, which includes a dexamethasone-based Induction, additional doses of pegaspargase (PEG-ASP) during Induction and Delayed Intensification (DI), and dexamethasone pulses during Maintenance therapy

3. To determine if prophylactic cranial radiation therapy (CRT) can be safely and effectively eliminated in the 85-90% of T-ALL patients classified asstandard or intermediate risk.

4.To determine the proportion of EOC MRD ? 0.1% T-ALL patients who become MRD negative (undetectable by flow cytometry) after intensification of chemotherapy, using three high risk (HR) BFM blocks, and to compare EFS between the patients who become MRD negative after the three HR BFM blocks and continue on chemotherapy with those who continue to have detectable MRD and are eligible for other treatment strategies, including hematopoietic stem cell transplant
Similarly, to compare the EFS between very high risk (Induction failure) T-LLy
patients treated with HR BFM intensification blocks who have partial or complete response (PR or CR) with those who do not respond (NR).

5. To investigate the prognostic significance of Day 29 BM MRD in T-LLy patients.

6. To determine if protein expression patterns can predict bortezomib response and drug resistance in T-ALL

7. To analyze and target relevant signaling pathways in T-ALL blasts, focusing on Early T cell Precursor ALL


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.


RTOG 1205: Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma

To establish an improvement in overall survival in recurrent GBM patients receiving bevacizumab and re-irradiation compared with patients receiving bevacizumab alone.
Secondary objectives include:
To estimate and compare the rate of objective response in patients with measurable disease.
To estimate and compare the 6-month progression-free survival rate.
To estimate and compare progression-free survival.
To estimate and compare the rate of treatment adverse events.
To estimate and compare the rate of ?grade 3 acute or delayed CNS toxicity.


A Phase III Trial of Adjuvant Chemotherapy as Primary Treatment for Locally Advanced Cervical Cancer Compared to Chemoradiation Alone: THE OUTBACK TRIAL (ANZGOG 0902/GOG-0274/RTOG 1174)

The aim of this study is to test the potential benefit of the addition of adjuvant chemotherapy following completion of primary chemoradiation for patients with locally advanced cervical cancer.
The primary objective will be to determine if the addition of adjuvant chemotherapy to standard cisplatin-based chemoradiation improves overall survival.
Secondary objectives will be to determine:
 Progression-free survival rates
 Acute and long-term toxicities
 Patterns of disease recurrence
 The association between radiation protocol compliance and outcomes
 Patient quality of life, including psycho-sexual health
Tertiary objectives will be to determine:
 The association between the results of a follow-up PET scan performed 4 - 6 months post completion of chemo-radiation and outcomes for all patients in the trial
 Biological predictors of patients outcomes based on translational laboratory studies of blood and tissue specimens


A Web-Based Multimedia Intervention for Head and Neck Cancer Patients

The objectives of the proposed study are to:
Aim 1. Develop a prototype web-based multimedia program that addresses four components, including: 1) Head and Neck Cancer and its Treatment; 2) Changes in Swallowing and Oral Care; 3) Changes in Speech; and 4) Coping with Cancer. We will create the content and develop a prototype web-based program that presents both didactic information and cognitive and behavioral strategies for coping with treatment of HNSCC. Material presented in the web-based program will include informational text, brief videos, and graphics and animation.

Aim 2. Evaluate acceptability and satisfaction with the prototype web-based program among 45 HNSCC patients and 5 expert professionals. Specifically, the prototype developed in Aim 1 will be evaluated by 45
patients who have recently completed radiation therapy and 5 healthcare professionals who work with the HNSCC patient population.

Exploratory Aim 3. Obtain preliminary data on potential program impact among 45 HNSCC patients. Measures of psychosocial functioning and self-efficacy will be assessed at pre- and post-program assessment, in order to obtain preliminary data on potential intervention impact. These data will be used to calculate potential effect sizes and support a future large-scale, randomized trial to evaluate the effectiveness of the web-based program in enhancing QOL among HNSCC patients.


NSABP B-51: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy NATIONAL SURGICAL ADJUVANT BREAST AND BOWEL PROJECT

To evaluate whether the addition of regional nodal radiation to chestwall and/or breast radiation will significantly reduce the rate of events for invasive breast cancer recurrence-free interval (IBC-RFI) in patients who present with histologically positive axillary nodes but convert to histologically negative axillary nodes following neoadjuvant chemotherapy.

PRIMARY AIMS: Ipsilateral recurrence-free interval, defined as time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer.

SECONDARY AIMS: Overall and disease-free survival, characterization of locoregional recurrence patterns, second invasive and/or in situ cancers, QOL, molecular marker predictors, effectiveness of adjuvant radiation techniques.