Our Clinical Trials
Breast
Locoregional breast cancer recurrence following targeted intraoperative radiotherapy (IORT) for ductal carcinoma in situ (DCIS)
Principal Investigator: Eileen Patricia Connolly, MD, PhD
NCT Number: NCT03216421
Population: Adult
Phase: II
The purpose of this study is to examine whether targeted Intraoperative Radiotherapy (IORT) is as effective as external beam radiation in treating DCIS and preventing it from returning. In addition, we will evaluate the side effects of IORT (toxicity), imaging changes, cosmetic appearance of the breast and your quality of life. In this study, subjects with DCIS will have IORT during with breast conserving surgery. Follow-up duration is 5 years. Are you Eligible? (Inclusion Criteria) To be eligible for this trial, patients must be: Female 18 years old or older with DCIS suitable for breast...
A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
Principal Investigator: Eileen Patricia Connolly, MD, PhD
NCT Number: NCT01570998
Population: Adult
Phase: IV
The purpose of this study is to evaluate the use of targeted intraoperative radiation therapy (IORT), where radiation is given one time during surgery. This study is being done to see if there are any differences between women who receive standard radiation after surgery versus those who have IORT. IORT is given during surgery after the tumor has been removed. The IORT device, called Intrabeam Device®, is FDA approved to be used in all parts of the body to deliver radiation. It can deliver radiation therapy accurately targeted to the area of the breast where the tumor has been removed...
Effects of MK-3475 on the breast tumor microenvironment in triple negative breast cancer with and without intra-operative RT: a window of opportunity study
Principal Investigator: Eileen Patricia Connolly, MD, PhD
NCT Number: NCT02977468
Population: Adult
Phase: I
Are you Eligible? (Inclusion Criteria) Participants must be/have: at least 21 years of age on the day of signing informed consent histologically proven invasive breast carcinoma with triple negative receptor status no evidence of metastatic disease no prior chemotherapy, radiation therapy, or breast resection within 6 months of study entry adequate organ function
S1706: A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently with Radiotherapy versus Radiotherapy Alone for Inflammatory Breast Cancer
Principal Investigator: Eileen Patricia Connolly, MD, PhD
Contact Number: 212-305-5050
NCT Number: NCT03598257
Population: Adult
Phase: II
This study is being done to answer the following question: Can we lower the chance of your cancer returning by adding the drug Olaparib to the usual radiation therapy for your cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your inflammatory breast cancer. The usual approach is defined as care most people get for inflammatory breast cancer when they have already received chemotherapy and had surgery to remove the cancer. Are you Eligible? (Inclusion Criteria) To be considered for this trial, subjects must have:...
Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer (CCTG MA.39)
Principal Investigator: Eileen Patricia Connolly, MD, PhD
Contact Number: 212-305-5050
NCT Number: NCT03488693
Population: Adult
Phase: III
The purpose of this study is to compare any good and bad effects of not giving regional radiotherapy to using regional radiotherapy. This study will help researchers learn if not giving regional radiotherapy is just as good as using regional radiotherapy. To be better, the approach of not giving regional radiotherapy should keep your breast cancer from coming back as good as giving regional radiotherapy. There will be about 2140 people taking part in this study. Are you Eligible? (Inclusion Criteria) To be eligible for this study, subjects must: 1. be ≥ 40 years of age. 2. have been...
Gastrointestinal (GI)
Audiovisual Didactic Experience for Latino patient treatment Adherence and Non-English speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology
Principal Investigator: Lisa Ann Kachnic, MD, FASTRO
Contact Number: 212-305-5050
NCT Number: NCT05351424
Population: Adult
Phase: II
In this study, you will be randomized to receive either a brochure or watch a video that discusses radiation and cancer clinical trials. In addition, you will complete questionnaires at seven time points: 1 questionnaire before radiotherapy, 4 questionnaires during the course of radiotherapy and 2 questionnaires at follow-up visits. The questionnaires and brochure or video administration will take place during your standard of care visits. Are you Eligible? (Inclusion Criteria) To be included in the main study, you must: 1. be age 18 years or older 2. be Spanish speaker of Latino Background...
SHOrt course Radiation and TASOX (TAS102 plus oxaliplatin) chemotherapy in operable rectal cancer, a phase II trial (Virginia Mason IRB CRP18085)
Principal Investigator: Lisa Ann Kachnic, MD, FASTRO
Contact Number: 212-305-5050
NCT Number: NCT04417699
Population: Adult
Phase: II
The main purpose of this study is to see if short-course radiation therapy followed by three months of chemotherapy with TAS-102 and oxaliplatin together (known as TASOX) is a safe and effective way to prepare patients for total mesorectal excision (a type of surgery for patients with advanced rectal cancer to remove the tumor and affected areas). Are you Eligible? (Inclusion Criteria) To be considered for this study, subjects should: -be 18 years of age or older -be newly diagnosed with rectal adenocarcinoma and meet other pathological requirements -have no metastatic disease and meet other...
Feasibility Study of Adaptive Radiotherapy for the Treatment of Locally-Advanced Anal Squamous Cell Carcinoma
Principal Investigator: Lisa Ann Kachnic, MD, FASTRO
Contact Number: 212-305-5050
NCT Number: NCT05838391
Population: Adult
The purpose of this study is to find out if performing adaptive planning during the treatment anal cancer will decrease the dose of radiation to normal organs and decrease the side effects. In this study, subjects will have a daily adjustment (adaptation) of their radiation plan as the tumor changes during the radiation treatment. The radiation will be given as part the standard of care treatment with chemotherapy, known as chemo-RT (CRT). Are you Eligible? (Inclusion Criteria) To be considered for this study, you must: 1. Have invasive anal cancer confirmed with biopsy 2. Be greater than 18...
A Randomized Phase II Study of De-Intensified ChemoRadiation for Early-Stage Anal Squamous Cell Carcinoma (DECREASE)
Principal Investigator: David P. Horowitz, MD
Contact Number: 212-305-5050
NCT Number: NCT04166318
Population: Adult
Phase: II
This study is being done to answer the following question: Is using a lower-dose regimen of chemoradiation therapy as effective and does it have fewer side effects, compared to the standard-dose regimen of chemoradiation therapy for patients with anal cancer? We are doing this study because we want to find out if this approach is better or worse than the usual approach for your anal cancer. There is not an established treatment that is individualized for patients with early-stage anal cancer. However, the usual approach is defined as care most people get for anal cancer. Are you Eligible? (...
Pilot study of intravenous contrast-enhanced cone beam CT in patients receiving radiotherapy
Principal Investigator: David P. Horowitz, MD
Contact Number: 212-305-5050
NCT Number: NCT04199754
Population: Adult
Phase: Early Phase I
The purpose of this study is to find out if giving intravenous (IV) contrast (a liquid that helps with the visibility of organs and blood vessels that is given through the vein with the use of a hollow needle) during a Cone Beam Computed Tomography (CBCT- a type of computerized X-ray) can help people who have image guided radiation therapy (IGRT) for the treatment of abdominal and pelvic tumors. Are you Eligible? (Inclusion Criteria) For inclusion in this study subjects: 1. Must be greater than or equal to 18 years of age. 2. Will require image guided external beam radiotherapy to abdominal...
Genitourinary (GU)
NRG-GU009: PARALLEL PHASE III RANDOMIZED TRIALS FOR HIGHRISK PROSTATE CANCER EVALUATING DE-INTENSIFICATION FORLOWER GENOMIC RISK AND INTENSIFICATION OF CONCURRENTTHERAPY FOR HIGHER GENOMIC RISK WITH RADIATION(PREDICT-RT*)
Principal Investigator: Israel Deutsch, MD
Contact Number: 212-305-5050
NCT Number: NCT04513717
Population: Adult
Phase: III
This study is being done in subjects that have high-risk prostate cancer, a low gene risk score and with a plan to receive radiation therapy to find out if: - A shorter hormone therapy treatment is as effective at controlling the prostate cancer compared to the usual 24-month hormone therapy treatment, or - If adding a new hormone therapy drug to the usual treatment increase the length of time without prostate cancer spreading as compared to the usual treatment. Depending on the group you are randomized to you could receive FDA-approved hormone therapy that you and your study doctor will...
Phase II single arm study testing SBRT, Adenosine signaling Modulation (AB680, AB928), and Immune Checkpoint inhibition (AB122) for men with hormone sensitive Oligometastatic prostate cancer (SBRT-AMICO)
Principal Investigator: Catherine S Spina, MD, PhD
Contact Number: 212-305-5050
NCT Number: NCT05915442
Population: Adult
Phase: II
This study aims to test the safety and effectiveness of zimberelimab, etrumadenant, and quemliclustat when given together with radiotherapy as a potential treatment to hormone sensitive oligometastatic (cancer that has spread to other areas of the body) prostate cancer. Zimberelimab, etrumadenant, and quemliclustat are considered immunotherapy drugs. These type of drug works by blocking a protein that can cause tumors to grow. By blocking this protein, the study drugs may cause your cancer to stop growing or to shrink. These study drugs are not approved by Health Authorities including the...
Pediatric/Young Adult
A Feasibility Study Examining the Use of Non-Invasive Focused Ultrasound (FUS) with oral Etoposide Administration in Children with Progressive Diffuse Midline Glioma (DMG)
Principal Investigator: Cheng-Chia Wu, MD, PhD
Contact Number: 212-305-5050
NCT Number: NCT05762419
Population: Pediatrics/Adult
Phase: NA
Children and young adults with diffuse midline glioma will be treated with Focused Ultrasound (FUS) with DEFINITY® microbubbles and neuro-navigator-controlled sonication. The overall goal of this study is to see if the study treatment plan will improve the outcome of participants with diffuse midline glioma, for which no known cure exists, and determine whether there are any clinical benefits of the study treatment. Children with progressive diffuse midline gliomas (DMGs) have very poor outcomes and have very limited options. One of the main obstacles in the effectiveness of medical...
A Phase I study examining the feasibility of intermittent convection-enhanced delivery (CED) of MTX110 for the treatment of children with newly diagnosed diffuse midline gliomas
Principal Investigator: Cheng-Chia Wu, MD, PhD
Contact Number: 212-305-5050
NCT Number: NCT04264143
Population: Pediatrics/Adult
Phase: I
The purpose of this study is to find the best dose of a drug called MTX110 and a contrast agent called gadolinium that can be given safely in children with newly diagnosed diffuse midline gliomas. All patients enrolled in the study will receive infusion of MTX110 and Gadolinium delivered with a pump directly into the tumor over 9-11 days. This is called a cycle chemotherapy and will be repeated one more time. The reason of using an experimental method of directly infusing the drug into the tumor is because the blood brain barrier (BBB) disallows drugs from successfully reaching the target...