Perelman School of Medicine at the University of Pennsylvania

Clinical Research | Breast and Gynecologic Cancers

Strategic Direction and Overarching Themes for the Service

Clinical and translational research in the breast and gynecologic team in the department of Radiation Oncology at the University of Pennsylvania focuses on:

  • The impact of radiation therapy on quality of life for women with breast and gynecologic cancers.
  • Developing methods for cardiac-sparing radiation therapy for women with breast cancer including prone positioning, respiratory gating and proton beam radiation.
  • Increasing the use of accelerated methods of radiation for breast cancer that aim to maintain the same rate of cure but decrease length of treatment and cost, and increase convenience of care.
  • Developing new methods to image cancers for radiation treatment planning and assessing response to therapy.
  • Exploring the role of proton therapy for women with breast cancer.
  • Exploring the role of proton therapy for women with cancers of the cervix and uterus.

Description of Programs and Protocols within the Service

Breast Cancer

Title: Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Trial

Principal Investigator: Justin E. Bekelman, M.D.
Coordinator: Natalie Rosetti
Office: (215) 614-6092
UPCC#: 19115

The Radiotherapy Comparative Effectiveness (RADCOMP) Consortium will conduct a pragmatic randomized clinical trial in which 1,716 patients with non-metastatic breast cancer involving lymph nodes under the arm or above the collarbone will be randomized after surgery to either proton therapy or photon therapy, the current standard treatment. Patients will be followed to determine differences in heart problems, cancer control, and health-related quality of life (HRQOL) after treatment. The primary outcomes are major cardiovascular events, such as heart attacks, chest pain, and other heart problems that patients and doctors care about. Cancer control outcomes include local-regional breast cancer recurrence and any breast cancer recurrence. HRQOL outcomes include body image and function, fatigue, anxiety, social roles, general HRQOL, side effects burden, financial burden, and satisfaction.

Title: A Randomized Study of the Effect of Yoga in Patients with Breast Cancer Receiving Radiation

Principal Investigator: Lilie Lin, M.D.
Coordinator: Natalie Rosetti
Office: (215) 614-6092
UPCC#: 08113

The purpose of this trial is to study the effect of Eischens yoga on radiation related fatigue and quality of life (QOL) in patients with breast cancer undergoing radiotherapy.  This randomized study has two cohorts: 1) twice-weekly Yoga sessions during radiation therapy, and 2) standard of care radiation therapy with supportive therapy instead of yoga.  All participants will be required to complete periodic questionnaires measuring cancer-related quality of life (FACT-G instrument) and fatigue (Brief Fatigue Inventory) throughout the duration of the study.

Title: A Feasibility and Phase II Trial of Accelerated Partial Breast Irradiation (APBI) Using Proton Therapy for Women with Stage IA-IIA Breast Cancer

Principal Investigator: Gary Freedman, M.D.
Coordinator: Natalie Rosetti
Office: (215) 614-6092
UPCC#: 04113

This study seeks to determine the feasibility, efficacy, and safety of proton beam therapy for APBI compared to traditional radiation and whole breast treatment therapies. Other objectives include examining the feasibility, side effects, and clinical efficacy of using proton therapy on the tumor bed of women being treated for breast cancer after surgical removal of malignancy. Women eligible for this study include those aged 50 years and older, receiving proton-beam radiation as adjuvant therapy, diagnoses of stage IA-IIA breast cancer, and have undergone breast-conserving surgery.

Title: The IDEA Study (Individualized Decisions for Endocrine therapy Alone): A Prospective, Single-Arm Cohort Study of Patients Receiving Endocrine Therapy Alone (without radiotherapy) After Breast Conserving Surgery for Early-Stage, Post-Menopausal Breast Cancer Patients Whose Tumors Have Favorable Biologic Features

Principal Investigator: Gary Freedman, M.D.
Coordinator: Ashley Feriozzi
Office: (215) 615-3272
UPCC#: 21115

This is a multi-site study whose purpose is to find out whether post-menopausal women, aged 50 to 69, who have early-stage cancer with favorable biological characteristics can safely avoid radiation treatment after a lumpectomy surgery. After lumpectomy surgery, doctors usually recommend radiation treatment to lower the risk of cancer coming back if the woman is under 70 years old. In some patients, it may be enough just to treat the cancer with a lumpectomy and endocrine therapy (a pill that acts to lower the effect of hormones also known as hormonal therapy or anti-hormonal therapy) that would be recommended anyway. We are conducting this research to see if subjects with this type of breast cancer will have a low risk of cancer coming back even without radiation. If that is true, then there may be more to lose than to gain from radiation.

Title: A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chest Wall & 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

Principal Investigator: Gary Freedman, M.D.
Coordinator: Susan Prendergast, BSN, RN
Office: (215) 662-4267
UPCC#: RTOG 1304

This randomized phase III trial studies standard or comprehensive radiation therapy in treating patients with early-stage breast cancer who have undergone surgery. The primary outcome is time from randomization until invasive local, regional, or distant recurrence, or death from breast cancer, assessed up to 10 years.

Title: A Phase IIR/III Trial of Standard of Care Therapy with or without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oliometastatic Breast Cancer

Principal Investigator: Gary Freedman, M.D.
Coordinator: Susan Prendergast, BSN, RN
Office: (215) 662-4267
UPCC#: NRG-BR002

Patients with locally controlled metastatic breast cancer and less than 2 metastases (at least 1 pathologically confirmed) visualized on CT or PET-CT are eligible for this study. Local regional disease must have undergone treatment at least 3 months prior to study registration per standard of care with no known residual disease. The primary objective is to determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients provides a sufficient signal for improved progression-free survival (PFS) to warrant full accrual to the Phase III portion of the trial. Another objective is to determine whether ablation (through SBRT and/or surgical resection of all known metastases) in oligometastatic breast cancer patients significantly improves overall survival (OS).

Title: A Phase III Trial of Accelerated Whole Breast Irradiation with Hypofractionation Plus Concurrent Boost vs. Standard Whole Breast Irradiation Plus Sequential Boost for Early Stage Breast Cancer

Principal Investigator: Gary Freedman, M.D.
Coordinator: Susan Prendergast, BSN, RN
Office: (215) 662-4267
UPCC#: RTOG 1005

It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery. The primary outcome is local control, i.e. time from randomization to the date of first local failure or last follow-up.

Gynecologic Cancers

Title: A Pilot Study to Assess the Suitability of DCE-MRI for Detection of Vascular Changes after Vaginal Brachytherapy

Principal Investigator: Lilie Lin, M.D.
Coordinator: Natalie Rosetti
Office: (215) 614-6092
UPPC#: 26812

This is a pilot study of DCE MR imaging to detect vascular changes in the vagina during and after radiotherapy in patients receiving adjuvant brachytherapy for cervical or endometrial cancer. All patients treated will receive a combination of external beam and intracavitary brachytherapy or intracavitary brachytherapy alone.  Patients on this study will receive 3 MRI scans at different time-points throughout their treatment. Vaginal toxicity is an important and poorly studied side effect of radiation therapy.  Understanding the pathophysiology behind vaginal fibrosis may inform future studies of radiation treatment using brachytherapy, including choice of dose and fractionation schedule. This study will provide preliminary data to be incorporated into future studies that will assess an intervention to prevent vaginal fibrosis/stenosis after radiation therapy in women treated for gynecologic malignancies.

Title: Fluorothymidine (FLT) PET/CT Imaging for Gynecologic Cancers

Penn Principal Investigator: Lilie Lin, M.D.
Coordinator: Natalie Rosetti
Office: (215) 614-6092
UPCC#: 28813

This study seeks to determine if a Positron Emission Tomography (PET/CT) scan, can help determine the right areas to target and avoid for radiation therapy and whether bone marrow is affected after radiation therapy has started.  The investigational imaging agent [18F] Fluorothymidine (FLT), a tracer for the PET/CT scan, will be tested in this study.  FLT has been used to identify areas of active bone marrow and tumor proliferation in other cancers, but it has not been used in PET/CT imaging for gynecologic cancers. To be eligible for this study, you must be at least 18 years of age, have a diagnosis of gynecologic cancer, and have been recommended to undergo treatment with either IMRT or proton therapy radiation with concurrent chemotherapy. Patient in this study will have 3 FLT injection PET/CT scans at different time points.  Additionally, blood samples will be collected to study biomarkers, which are molecules that are used to see how the body is responding to study therapy and to help us understand more about patient’s type of cancer.  Patients will also be required to complete several questionnaires about their general health, symptoms, well-being, and concerns related to cancer.

Multi-Site Cancers

Title: Assessing the Impact of Electronic Capture of Patient Reported Outcomes in Radiation Oncology

Principal Investigator: Lilie Lin, M.D.
Coordinator: Alisha Maity
Office: (215) 662-6347
UPCC#: 24915

Potential study subjects must have breast cancer, lung cancer, head and neck cancer, or gynecologic cancer and be receiving definitive external beam radiotherapy. The goals of this study are (1) to assess the feasibility of weekly administration of site specific patient reported assessments using an electronic platform, (2) to assess the psychometric properties (validity, reliability, responsiveness to change, utility) of anatomic site specific patient version of the common terminology criteria for adverse events (PRO-CTCAE) item sets in measuring radiation induced toxicities, and (3) to explore the correlation between patient reported outcomes using the PRO-CTCAE vs. physician reported outcomes using CTCAEv4.0 and well as known dosimetric prognostic factors in patients with lung, breast, head and neck, or pelvic malignancies.

Title: Phase I/II Trial of Pre-Operative Image Guided Intensity Modulated Proton Radiation Therapy (IMPT) or Photon (IMRT) with Simultaneously Integrated Boost to the High Risk Margin for Retroperitoneal Sarcomas

Principal Investigator: William Levin, M.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 4214

This is a Phase I/II study of pre-operative image guided IMPT (IG-IMPT) or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. The phase I portion of this study will evaluate up to four dose levels of IGIMPT or IMRT with simultaneously integrated boost (SIB) to the high risk margin of retroperitoneal sarcoma. Once the maximum tolerated dose (MTD) is determined (Phase I), participants will be accrued to the Phase II treatment using the combination of IG-IMPT or IMRT with SIB to determine if there is a sufficient signal, with respect to local recurrence, to warrant pursuing a large phase IIR or phase III trial.

Title: Retreatment of Recurrent Tumors Using Proton Radiotherapy

Principal Investigator: John P. Plastaras, M.D., Ph.D.
Coordinator: Kristi Lelionis, MS, CCRP
Office: (215) 615-3273
UPCC#: 23309

The purpose of this study is to determine the feasibility of using proton radiotherapy for reirradiation of recurrent malignancies. The primary outcomes are feasibility and acute toxicity. The study is infeasible if patient cannot be given treatment. Patient is unable to tolerate 15% treatment. patient is unable to complete all of his/her treatments within 10 days of estimated date of treatment completion. Acuite Toxicity is defined as any grade 4 toxicity observed within 90 days from the initiation of radiotherapy that is felt to be directly related to their proton treatment. Toxicities will be graded by NCI CTC Version 4.0. Patients will be stratified by treatment site (Head and Neck, Thorax, Abdomen, Pelvis, Extremities) and by treatment volume (low volume, high volume) for a total of 10 strata. This study will be done in two phases. In the first phase, feasibility will be established using the primary objectives set below. The second phase will begin no earlier than 90 days after the last patient in the initial phase has completed treatment in each strata and once feasibility has been verified.

Title: Prospective Follow-Up of Outcomes in Patients Receiving Photodynamic Therapy for Neoplastic Diseases

Principal Investigator: Charles Simone, M.D.
Coordinator: Ashley Feriozzi
Office: (215) 615-3272
UPCC#: 06911

This is an observational study for subjects who are age 18 or older and will undergo Photodynamic Therapy (PDT) for a diagnosis of neoplastic disease under the direction of a Penn physician. The purpose of this study is to learn and understand more about how PDT works. To do this we need to study the experiences of patients who undergo PDT and examine things like tumor type, other medical conditions, other therapies and treatment results.

There are no interventions being performed and only medical record data will be collected. We will collect your name, medical record number, date of birth, date of initiation of specific therapies such as surgery, radiation or PDT. This information will not be disclosed to others outside of the study team. The entire study is anticipated to take 10 years. Asubject will be in the study until they inform us that they no longer wish to participate.

Title: RADVAX: A Stratified Phase I Trial of Pembrolizumab with Hypofractionated Radiotherapy in Patients with Advanced and Metastatic Cancers

Principal Investigator: Amit Maity, M.D. Ph.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 40914

Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other).

Publications from the Service Members

Justin E. Bekelman, M.D. (PubMed)
Gary Freedman, M.D. (PubMed)
Lilie Lin, M.D. (PubMed)



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