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Radiation Oncology

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Clinical Trials

Prone partial breast irradiation (PBI): Prospective randomized controlled non-inferiority trial to compare radiation fibrosis with five versus three fractions

IRB Protocol #:1505016201   NCT # NCT02755896 

  • Purpose of trial and sponsorship: The purpose of this study is to compare two different regimens of partial breast radiation treatment in post-menopausal women with breast cancer. Endpoints of the study are local control rates and incidence of long-term effects of radiation fibrosis (thickening or firming of the breast that can be a side effect of radiotherapy) and other skin changes post-radiation treatment. The Principal Investigator for this study is Dr.Silvia Formenti, M.D.This trial is sponsored by Radiation Oncology department at Weill Cornell Medicine, New York.
  • Patient Participation Criteria: This trial is open to post-menopausal women who have been diagnosed with Stage 1 breast Cancer, also known as T1 breast cancer and women with Stage 0 (Tis) DCIS, non-invasive cancer.
  • Open to Accrual: Yes

Accelerated Radiation Therapy (ART) To the Breast and Nodal Stations after Neo-Adjuvant Chemotherapy and Surgery: A Feasibility Study

IRB # 1602017017       NCT # NCT02917421

  • Purpose of trial and sponsorship: A prospective study to test feasibility of probe breast and nodal radiotherapy in women who have undergone surgery after preoperative systemic therapy. The study aims to test the use of an accelerated regimen of intensity modulated radiation therapy (IMRT) to treat both breast and lymph nodes. This is a technique for delivering radiation to the entire breast tissue/chest wall and the lymph nodes that drain the breast and that are not surgically examined at the time of breast surgery in a more precise and even dose that reduces the length of the treatment from 6 to 3 weeks. The Principal Investigator for this study is Dr.Silvia Formenti, M.D. This trial is sponsored by Radiation Oncology department at Weill Cornell Medicine, New York.
  • Patient Participation Criteria: This trial is open to newly diagnosed Stage I-III breast cancer patients with an indication for post-operative radiotherapy after neo-adjuvant chemotherapy and surgery.
  • Open to Accrual: Yes

A Phase II randomized controlled trial of PD-1/PDL-1 axis blockade versus PD-1/PDL-1 axis blockade plus radiotherapy in metastatic genitourinary (renal/urothelial) malignancies

IRB# 1606017369   NCT # NCT03115801 

  • Purpose of trial and sponsorship: The purpose of this study is to assess the response rate of immunotherapy alone versus immunotherapy and radiation therapy to a single lesion in patients with renal cell carcinoma and bladder cancer, and to estimate the difference in response rates between these two treatment groups. The type of immunotherapy that a patient receives will be based on the cancer type. Renal Cell Carcinoma patients will receive Nivolumab as their immunotherapy regimen, while Bladder cancer patients will receive atezolizumab/ pembrolizumab as their immunotherapy regimen. In addition to this, the study also intends to examine the association of clinical responses with an anti- tumor immune response and to assess the toxicity of immunotherapy with radiation therapy. The Principal Investigator for this study is Dr.Himanshu Nagar M.D. This trial is sponsored by Radiation Oncology department at Weill Cornell Medicine, New York.
  • Patient Participation Criteria: Histologic diagnosis of metastatic renal cell carcinoma or urothelial cancer. Any prior therapy is permitted except prior therapy with PD1/PDL1 inhibitor. Patients must have at least 2 distinct measurable metastatic sites at least 1 cm or larger in their largest diameter per RECIST 1.1
  • Open to Accrual: Yes

Radiation and immune checkpoints blockade in metastatic NSCLC (BMS # CA209-632)

IRB # 1607017434      NCT # NCT03168464

  • Purpose of trial and sponsorship:This research study is being done to see if the overall response rate in metastatic non-small cell lung cancer can be increased by using the combination of radiation and  infusion drugs ipilimumab and nivolumab to increase the overall response rate in lung cancer patients who have stopped responding (become refractory) to chemotherapy. The Principal Investigator for this study is Dr.Silvia Formenti, M.D. This study is sponsored by Bristol-Myers Squibb.
  • Patient Participation Criteria: Any KRAS or EGFR status is acceptable; Patients with an EGFR sensitizing mutation must have received an EGFR tyrosine kinase inhibitor (either erlotnib, gefitnib or afatinib) and patients with ALK translocation must have received anti-ALK therapy. Patients must have at least two distinct measurable metastatic sites, with one of at least 1 cm or larger in its largest diameter. Patients may have additional non-measurable metastatic lesions (e.g., bone metastases)
  • Open to Accrual: Yes 

A Randomized Phase III Trial of Hypofractionated Post-Prostatectomy Radiation Therapy (HYPORT) Versus Conventional Post-Prostatectomy Radiation Therapy (COPORT)

IRB # 1708018460     NCT # NCT03274687

  • Purpose of trial and sponsorship: The purpose of this study is to compare the effects of Hypofractionated radiation therapy (using radiation therapy at a higher dose given with each radiation treatment for a shorter length of time) to radiation therapy given for the standard length of time to prostate cancer patients treated with surgery. This includes patients in which not all of the cancer was removed with surgery the prostate specific antigen level (PSA) level indicated that cancer has persisted or returned. The Principal Investigator for this study is Dr.Himanshu Nagar, M.D. This study is sponsored by Clinical Trials Cooperative Group Study NRG-GU003.
  • Patient Participation Criteria: Confirmation of adenocarcinoma of the prostate treated primarily with radical prostatectomy. Interested patient should have one of the following pathologic T-classifications: pT2 or pT3 and there should be no clinical evidence of regional lymph node metastasis.
  • Open to Accrual: Yes

Effect of radiotherapy variables on circulating effectors of immune response and local microbiome

IRB # 1708018471 NCT # NCT03383107

  • Purpose of trial and sponsorship: Exposure to radiation can impact immune cells that are present in the blood, such as lymphocytes. It is hypothesized that larger radiation fields and/or longer courses of radiation, result in greater decrease in immune cells. To test this hypothesis, the study will collect blood samples from subjects undergoing two different standard of care radiation regimens for prostate cancer, and subjects undergoing two different standard of care regimens for breast cancer. These treatment regimens vary by total dose, number of treatments, and/or size of the radiation target, and will allow us to study the impact of radiation variables on the immune system. It is possible that these radiation regimens impact the immune system and normal bacteria (microbiota) in different ways. The study also aims to analyze microbiome changes and immune mediators (i.e. lymphocytes, cytokines) present in blood samples before, during and after radiation; and explore the association between these parameters and type of radiation received. The Principal Investigator for this study is Dr.Silvia Formenti, M.D and the Co-Principal Investigator is Dr.Josephine Kang, M.D.The study is sponsored by Varian Medical Systems.
  • Patient Participation Criteria: Biopsy-proven diagnosis of prostate adenocarcinoma for prostate cancer patients or biopsy-proven diagnosis of invasive breast cancer, status post breast surgery to negative margins, and requiring adjuvant breast and nodal RT.
  • Open to Accrual: Yes

An Open-Label Multicenter Phase 1b Study of E7046 in Combination with Radiotherapy/ Chemo radiotherapy (RT/CRT) in preoperative treatment of Subjects with Rectum Cancer

IRB # 1612017834   NCT # NCT03152370 

  • Purpose of trial and sponsorship: This clinical trial is for men and women age ≥ 18 years old who have been diagnosed with advanced rectum cancer.  This is a phase 1b study to assess the safety and tolerability of the investigational study drug, E7046, which is manufactured by Eisai Inc., in combination with preoperative radiotherapy and chemotherapy in the short course and long course radiotherapy settings. The primary objective of this study is to find a safe dose level of the investigational study drug, E7046 in combination with radiotherapy and chemotherapy.  Other objectives of the study are to determine the maximum tolerated dose and/or recommended phase 2 dose of E7046 in combination with preoperative radiotherapy and chemotherapy. Currently available treatments are effective in some patients but many experience side effects. Therefore, there is a need to find more effective treatments with fewer side effects. The Principal Investigator for this study is Dr.John Ng, M.D. This study is sponsored by Eisai Inc. / Adlai Nortye.
  • Patient Participation Criteria: This trial is open to men and women, Age ≥18 years at the time of informed consent who have been diagnosed with invasive primary rectal cancer. No prior pelvic radiotherapy, chemotherapy, immunotherapy or other anti-cancer treatment for rectal cancer is acceptable.
  • Open to Accrual: Yes

For further information, please contact:

IRB # 1604017139 Randomized trial of image-guided stereotactic radiation therapy  (IG-SRT) in prostate cancer NCT02911922
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This study is closed.

IRB # 1602017017 Accelerated Radiation Therapy (Art) To The Breast And Nodal Stations After Neo-Adjuvant Chemotherapy And Surgery: A Feasibility Study NCT02917421
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This study is currently recruiting participants.

IRB # 1505016229 A First-in-Human Study of Repeat Dosing with REGN2810, a Monoclonal, Fully Human Antibody to Programmed Death - 1 (PD-1), as Single Therapy and in Combination with Other Anti-Cancer Therapies in Patients with Advanced Malignancies NCT02383212
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This study is open but closed to accrual participants.

IRB # 1505016222 LY2157299 Monohydrate (LY2157299) and Radiotherapy in Metastatic Breast Cancer NCT02538471
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This study is open but closed to accrual participants.

IRB # 0810010069 RTOG0534: A Phase III Trial of Short Term Androgen Deprivation with Pelvic Lymph Node or Prostate Bed Only RT (SPORT) in Prostate Cancer Patients with a Rising PSA after Radical Prostatectomy NCT00567580

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This study is open but closed to accrual participants.

IRB # 1505016228 Phase I/II study of TLR7 agonist Imiquimod, Cyclophosphamide, and Radiotherapy in Breast Cancer Patients with Chest Wall Recurrence or Skin Metastases NCT01421017
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This study is open but closed to accrual participants.

Clinical Trials Contact Information

Stich Radiation Oncology Clinical Trials

Maria Fenton-Kerimian,N.P.
Tel: (212) 746-6074

Sharanya Chandrasekhar
Tel: (646) 962-2196
email: shc2043@med.cornell.edu

Pragya Yadav

Tel: (646) 962-2199
email: pry2003@med.cornell.edu

Contact Us

Stich Radiation Oncology Center

New York-Presbyterian Hospital/
Weill Cornell Medical Center
525 East 68th Street
New York, NY 10065
Tel: (212) 746-3600
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The Arnold Center For Radiation Oncology

New York Hospital Queens

56-45 Main Street
(56th Avenue between Main Street and 141st Street)
Flushing, NY 11355
Tel: (718) 670-1501

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New York-Presbyterian/
Lower Manhattan Cancer Center

21 West Broadway
New York, NY 10003
Tel: (212) 746-6600

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