Clinical Studies

Clinical Trials at the Department of Radiation Oncology

A phase I trial assessing the safety and feasibility of prophylactic nipple-areola complex (NAC) irradiation after nipple-sparing mastectomy and immediate reconstruction in patients with in-situ or invasive breast cancer
Principal investigator: Cristiane Takita, MD

The purpose of this research study is to see if we can safely preserve the nipple and areola, of women undergoing a mastectomy for breast cancer or pre cancerous lesion. The women enrolled on this trial will have a nipple-sparing mastectomy with immediate reconstruction of your breast and will then receive a short course of radiation.
With this study we hope to learn about not only how satisfied women are with the way they look, after the surgery and radiation, but also learn about the effects of this combination of treatment. Studies have shown that women who have a mastectomy have a higher risk of the cancer coming back if they had a mastectomy, preserving the nipple and areola. This trial will indicate if the addition of radiation therapy to the nipple area could address this risk of recurrence. A mastectomy, with removal of the breast, including the nipple and areola, is the standard surgical treatment for patients with cancer or pre-cancerous breast lesion that want or need a mastectomy. In general, the radiation treatment is given daily over a period of 5 weeks. Recent studies have shown that it is possible and safe to deliver radiation over a shorter period of 5 to 10 days.

Something about the Principal Investigator:
This institutional study is an initiative of Dr. Cristiane Takita, a radiation oncologist at Sylvester Comprehensive Cancer Center for more than 15 years. Dr. Takita is a respected medical expert in the field of radiation treatment and breast cancer. She understands the importance of achieving the best cosmetic outcomes for women undergoing mastectomy.

Gynecologic Cancer

A Randomized Phase III Study of concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High Risk Patients with Early-Stage Cervical Carcinoma Following Radical Hysterectomy/ RTOG 0724
Principal investigator: Aaron Wolfson, MD

The purpose of this study is to compare the effects of giving additional chemotherapy after the usual treatment of chemotherapy and radiation for patients who underwent surgery for cervical cancer.

The standard treatment for patients who are found to have risk of disease recurrence after surgery for cervical cancer is to deliver a course of pelvic radiation with weekly chemotherapy. The study will determine whether adding chemotherapy with carboplatin and paclitaxel to standard treatment could improve survival. This trial will also look at biologic factors that may help to predict and treat cervical cancer. It will also gather information about the effects of radiation therapy and chemotherapy on quality of life. If you have been diagnosed with cervical cancer, and underwent surgery, this trial may be appropriate for you.

The principal investigator Dr. Aaron Wolfson has many years of experience treating patients with gynecological cancer. He is a member of gynecology oncology group endometrial cancer steering committees and he collaborated to the development of national consensus on the management of women with gynecological cancer.

A Randomized Phase III Study of Standard Versus Intensity Modulated Pelvic Radiation for Post-Operative Treatment of Endometrial and Cervical Cancer/ RTOG 1203

Principal Investigator: Lorraine Portelance, MD

The purpose of this study is to test whether the use of a radiation therapy technique called intensity-modulated radiation therapy (IMRT) can reduce the amount and severity of gastrointestinal side effects (such as diarrhea) that result from radiation, compared with standard radiation techniques. Patients diagnosed with either cervical or endometrial cancer who underwent surgery could be eligible to participate in this clinical trial. The patients enrolled on this trial will fill detailed quality of life studies throughout the course of their treatment.

About the Principal investigator:
The principal investigator, Dr. Portelance, is a national leader in the use of IMRT for patients with gynecological malignancies.

Head and Neck Cancer

A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for locally-advanced Resected Head and Neck Cancer/ RTOG 0920
Principal investigator: Michael Samuels, MD

This trial is for the patient with squamous cell cancer of the head and neck after surgery. The pathology report must show that the tumor has certain characteristics that put the patient at risk of tumor re-growth. The patient is randomly assigned to receive radiation therapy alone after surgery vs. radiation therapy combined with a targeted anti-cancer drug called cetuximab.

When the study is completed, we hope to show whether the addition of cetuximab to radiation therapy reduces tumor regrowth in this group of patients.

About the Principal Investigator: Dr. Michael Samuels is an experienced head/neck cancer radiation oncologist and investigator with interests in improving the effectiveness of radiation therapy for head and neck cancers while minimizing toxicity. He is the Medical Director for Sylvester Clinical Research Services, which is the office that supports all therapeutic clinical trials in the Cancer Center.

A Randomized Phase II Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High-Risk Malignant Salivary Gland Tumors/ RTOG 1008
Principal investigator: Michael Samuels, MD

This trial is designed for the patient with cancer of the salivary glands after surgery, if the pathology report shows certain features that put the patient at high risk of tumor re-growth. It assigns patients randomly to radiation therapy alone vs. radiation therapy plus chemotherapy (cisplatin given once weekly). The study hopes to determine whether the addition of weekly cisplatin chemotherapy to radiation reduces the rate of tumor regrowth in this high-risk group of patients.

A word about the Principal Investigator: Dr. Michael Samuels is an experienced head/neck cancer radiation oncologist and investigator with interests in improving the effectiveness of radiation therapy for head and neck cancers while minimizing toxicity. He is the Medical Director for Sylvester Clinical Research Services, which is the office that supports all therapeutic clinical trials in the Cancer Center.

Neurological Cancer

Randomized Phase II Trial of Concurrent Bevacizumab and Re-Irradiation Versus Bevacizumab Alone as Treatment for Recurrent Glioblastoma/ RTOG 1205
Principal Investigator: Fazilat Ishkanian, MD, PhD

Bevacizumab is a commercially available drug that is FDA approved for the treatment of glioblastoma that has returned after treatment (recurrent glioblastoma). However, treatment with bevacizumab alone has only modestly improved survival in patients with this type of brain tumor.

For this reason, researchers are evaluating other treatments, including bevacizumab combined with radiation. The purpose of this study is to determine whether adding radiation to bevacizumab is more effective than using bevacizumab alone to treat recurrent glioblastomas..

In this trial patients will be randomly assigned to receive either bevacizumab alone or bevacizumab and radiation therapy.

About the Principal Investigator: Fazilat Ishkanian, MD, PhD
Dr. Ishkanian specializes in treating brain tumors using the most current radiation techniques including IMRT, IGRT and stereotactic radiosurgery including Gamma Knife. She has a strong interest in clinical trial research and is dedicated to improving the outcomes and lives of patients diagnosed with primary or metastatic brain cancer.

Pancreatic, Liver, and Related Cancers

A Phase III Trial Evaluating Both Erlotinib and Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma/RTOG 0848

Principal investigator: Lorraine Portelance, MD.

The standard treatment for patients with pancreatic cancer that was removed by surgery is to receive the chemotherapy drug gemcitabine, to decrease the risk of having a cancer recurrence. In this study, you will get either gemcitabine alone or gemcitabine combined with erlotinib. Erlotinib is a pill that may help treat cancers by blocking a gene that is important in cancer growth. This study will compare the effects of the drug erlotinib in combination with gemcitabine to gemcitabine alone for patients with pancreatic cancer that was removed by surgery to find out which is better. This study will also determine the effects of radiation for patients who remain disease-free after gemcitabine chemotherapy. This study is enrolling patients in many centers in North America.

About the Principal Investigator: Lorraine Portelance, M.D

The institution, principal investigator, Dr. Portelance has many years of experience at conducting clinical trials and is currently the director of the radiation oncology clinical research program. She is committed to contribute to the development of new innovative approaches to treating patients diagnosed with cancer, allowing for better disease control and less treatment toxicity.

Prostate, Bladder, and Kidney Cancers

A Randomized Study of Radiation Hypofractionation via Extended versus Accelerated Therapy (HEAT) For Prostate Cancer

Principle Investigator: Matthew C. Abramowitz M.D.

The purpose of this research study is to compare the side effects and effectiveness of two different radiation therapy regimens to the prostate: the first one (the standard one) is given Monday through Friday five days a week for 26 visits and the other is given over 5 visits every other day except on the weekends.

External beam radiation therapy is a type of radiotherapy, which is a common treatment for men with prostate cancer. Even though radiation treatments are effective, standard courses of treatment can take 2 1/2 months to deliver. This represents a significant burden for patients and their families. Recently, treatments of just over five weeks and as short as two weeks have been evaluated and have shown comparable cure rates and risks as longer treatment courses. By shortening the course of treatment, we hope to improve the convenience and decrease the burden of cancer treatment for patients and their families. However, shortening the course of treatment may come with an increased risk of late side effects.

The use of stereotactic radiotherapy and improved technologies will increase the accuracy of our radiation delivery and decrease the amount of normal tissue that receives the high doses of radiation, should enable us to deliver these short courses of radiation safely.

We would like to determine the effectiveness of this new shorter radiotherapy by evaluating the side effects experienced during treatment. We will be evaluating whether the rates of cancer returning or remaining in the prostate are the same or better in either treatment arm 2 years after treatment. The side effects of the shorter treatment arm will be compared to those of the standard treatment arm. We also interested in looking at the cure rate five years after treatment has finished as determined by PSA measurements

A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy (RT) With or Without Short-Term Androgen Deprivation Therapy (ADT) for Patients With Intermediate-Risk Prostate Cancer
Principal investigator: Alan Pollack, MD, PhD

This trial is designed for patients who have not received prior treatment for their prostate cancer. Prior studies have shown possible advantages to the use of hormone therapy with radiation. However, those studies used a radiation technique that is no longer commonly used in clinical practice. This study will be testing to see if there are similar benefits for hormone therapy when used with current radiation therapy techniques (dose-escalated radiotherapy). Patients will be assigned randomly to radiation therapy alone vs. radiation therapy plus hormone therapy. The study hopes to determine if the side effects of hormone therapy are outweighed by the advantages in prostate cancer cure rates.

A Phase III Randomized Trial of MRI-Mapped Dose-Escalated Salvage Radiotherapy Post-Prostatectomy: The MAPS Trial

Principle Investigator: Matthew C. Abramowitz M.D.

The purpose of this research study is to determine the effectiveness of extra radiation treatment of high dose (“boost”) to the tumor in your prostate bed in addition to standard radiation dose. We will compare this combined treatment to standard radiation therapy alone to the prostate bed. External beam radiation therapy is a type of radiotherapy, which is a common treatment for men with prostate cancer. Even though radiation treatments are effective, there is evidence that giving higher radiation doses to the prostate bed will result in further significant gains in controlling the cancer. However, higher radiation doses to the prostate bed are associated with an increased risk of side effects. For this reason, we have designed a very focused treatment of high dose boost of radiation delivered to the regions of the prostate bed indicated to have a tumor based on magnetic resonance imaging (MRI) scans done with intravenous contrast injection to better visualize the location of the tumor in the prostate bed.

Advances in MRI have resulted in much better accuracy in determining where the bulky tumor areas are located, so that these may be better targeted with radiation. The addition of a high dose radiation boost may improve tumor removal without increasing side effects. There is some evidence that giving such a focused high dose boost of radiation may be more effective at killing prostate bed cancer cells, but few studies of this type have been done previously.

A Phase III Trial Of Hypofractionated External Beam Image-Guided Highly Targeted Radiotherapy: The HEIGHT Trial
Principal investigator: Alan Pollack, MD, PhD

This trial is designed for patients with prostate cancer, who have not been previously treated with radiation therapy or surgery, and who have certain characteristics on an MRI scan of the prostate. External beam radiation is a type of radiation therapy that is a common treatment for men with prostate cancer. Even though radiation treatments are effective, there is evidence that giving higher radiation doses to the prostate will result in further significant gains in controlling the cancer. However, higher radiation doses to the entire prostate are associated with an increased risk of side effects. For this reason, we have designed a very focused high dose boost of radiation delivered to the regions of the prostate indicated to have a tumor based on MRI scans with each daily treatment, in addition to standard doses to the rest of the prostate.

Patients will be assigned randomly to standard radiation therapy of rather uniform dose to the prostate vs. standard radiation therapy to the prostate plus a higher daily dose (boost) to the MRI-identified tumor areas. The purpose of the study is to determine if the high dose tumor boost results in more complete tumor disappearance from the prostate at 2.0-2.5 years after completion of the treatment.

A Phase I Trial of MRI-Guided Lattice Extreme Ablative Dose Radiotherapy For Prostate Cancer
Principal investigator: Alan Pollack, MD, Ph.D.

This trial is designed for patients with prostate cancer, which has not been previously treated with radiation therapy or surgery. The purpose of the study is to examine the safety of a one-time extra radiation treatment of high dose (boost) combined with standard radiation. Patients may or may not receive hormone therapy, at the discretion of their radiation oncologist. External beam radiation therapy, with or without hormone therapy, is one of the standard treatments for men with prostate cancer. Even though radiation treatments are effective, there is evidence that giving higher radiation doses to the entire prostate are associated with an increased risk of side effects. For this reason, we have designed a very focused treatment of high dose boost of radiation delivered to regions of the prostate indicated to have a tumor based on MRI scans. The addition of a high dose focused radiation boost may improve tumor elimination without increasing side effects. There is some evidence that giving such a focused high dose boost of radiation may be more effective at killing prostate cancer cells, but no prior studies of this type have been done previously.

The main goal of this study is to determine the side effects of treatment using the high dose boost. A secondary goal is to determine how often tumor cells are found in prostate biopsy tissue at 2-2.5 years after radiation therapy.