Department of Radiation Oncology

Clinical Research Thoracic Cancers

Strategic Direction and Overarching Themes for the Service

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Description of Programs and Protocols within the Service

Title: The Detection of Circulating Tumor Cells (CTC) in Patients with Non-Small Cell Lung Cancer (NSCLC) Undergoing Definitive Radiotherapy or Chemoradiotherapy

Principal Investigator: Charles Simone, M.D.
Coordinator: Chimbu Chinniah
Office: (215) 662-4726
UPCC#: 12512

This study seeks to describe the pattern of CTC detection in the blood of NSCLC patients undergoing definitive radiation therapy and the intra- and inter-patient variability at baseline and test/re-test reliability of a novel CTC detection assay. Eligible patients are those 18 years and older capable of providing informed consent with biopsy proven NSCLC undergoing definitive radiotherapy. Patients are divided into 7 cohorts: patients with early stage NSCLC undergoing stereotactic radiotherapy, patients with locally advanced NSCLC undergoing standard chemoradiotherapy, patients with stage I-III NSCLC undergoing standard, fractionated radiotherapy alone, patients with locally advanced NSCLC undergoing standard chemoradiotherapy with the novel signal transduction inhibitor nelfianvir, patients with resectable stage IIIa NSCLC undergoing pre-operative chemoradiotherapy, patients with suspected (no tissue diagnosis) early stage NSCLC undergoing stereotactic radiotherapy, and lastly, patients with locally advanced NSCLC undergoing stereotactic radiotherapy followed by concurrent mediastinal chemoradiotherapy. Patients on study will have blood collections at several different time points.

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Title: The Utility of Circulating Tumor Cells as Confirmation of Pathologic Diagnosis in Patients with Suspected Early Stage Non-small Cell Lung Cancer

Principal Investigator: Charles Simone, M.D.
Coordinator: Chimbu Chinniah
Office: (215) 662-4726
UPCC#: 02515

The primary objective of this study is to determine whether circulating tumor cells (CTCs) can be used as a non-invasive means of confirming pathologic diagnosis in early-stage (Stage I) non-small cell lung cancer (NSCLC) in patients. Blood will be collected from enrolled patients at three time points surrounding surgical intervention to test for CTCs. Presence of CTCs will be compared to the final pathologic diagnosis based on surgical specimens to assess the sensitivity of using CTCs alone to make a definitive diagnosis. 

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Title: Feasibility and Phase I/II Trial of Preoperative Proton Beam Radiotherapy with Concurrent Chemotherapy for Resectable Stage IIIA or Superior Sulcus NSCLC

Principal Investigator: Charles Simone, M.D.
Coordinator: Susan Mazzoni, MPH
Office: (215) 662-4726
UPCC#: 25508

The primary objective of this interventional study is to evaluate the feasibility of proton beam radiotherapy in treating NSCLC patients receiving radiation with concurrent chemotherapy followed by surgical resection. Secondary objectives of the study include assessing acute and late side effects of proton therapy compared to conventional photon therapy and the dose distribution of radiation to the tumor and surrounding tissues compared to conventional photon beam therapy. Patients on study will receive proton beam therapy with concurrent standard of care chemotherapy followed by surgery approximately 30 days following completion of radiotherapy. Patients will receive weekly standard of care CBC w/differential lab draws while receiving chemo to assess suitability for chemo administration. Upon completion of radiation and surgical resection patients will be seen for follow up as per standard of care including MRI and PET/CT scans every 3 months for 2 years then every 6 months thereafter for 3 years.

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Title: A Randomized Phase II Trial of Radical Pleurectomy and Post-Operative Chemotherapy with or without Intraoperative Porfimer Sodium-Mediated Photodynamic Therapy for Patients with Epithelioid Malignant Pleural Mesothelioma

Principal Investigator: Keith Cengel, M.D., Ph.D.
Coordinator: Sally McNulty, RN, CCRP
Office: (215) 662-7720
UPCC#: 14513

This is a randomized Phase II trial designed to test whether the addition of intraoperative Photofrin-mediated photodynamic therapy to radical pleurectomy and post-operative chemotherapy improves overall survival in the treatment of patients with epithelioid malignant pleural mesothelioma (MPM). Subjects with resectable, epithelioid MPM will be randomly assigned to surgery with PDT vs. surgery alone. Subjects assigned to the PDT arm will be given the photosensitizer Photofrin prior to surgery at a dose of 2 mg/kg given approximately 24h prior to surgery. All subjects will receive maximal surgical debulking via radical pleurectomy with the goal of producing a macroscopically complete surgical resection (MCR). After maximal surgical resection, subjects assigned to the PDT arm will receive intraoperative treatment with 630 nm light to a dose of 60 J/cm2 using real-time, isotropic light dosimetry. All subjects will receive post-operative adjuvant chemotherapy. This trial will be performed with the primary endpoint of overall survival and secondary endpoints of progression free survival, as well as analysis of normal and malignant tissues and serum for cellular, microenvironmental and immunologic endpoints.

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Title: Evaluating an Anchored Transponder in Lung Cancer Patients Receiving Radiation Therapy to the Lungs

Principal Investigator: William Levin, M.D.
Coordinator: Sally McNulty, RN, CCRP
Office: (215) 662-7720
UPCC#: 10514

The purpose of this multi-site study is to evaluate a new anchored transponder in patients with cancers of the lung receiving radiation therapy. The study aims to show that it is safe, feasible, and possible to localize (i.e., calculate the position of) patients with implanted anchored transponders, that will remain in the lung, using the Calypso System. Additionally, the protocol is designed to demonstrate the potential benefit to the patient in terms of reducing the radiation dose to adjacent normal tissues. This is made possible by reducing the planning target volume (PTV) when real-time localization and tracking are available to manage respiratory motion. Patients will be on study prior to their radiation treatment (approximately 0.5 months), during their radiation treatment (approximately 0.5-1.5 months depending on whether they receive hypofractionated stereotactic or conventionally fractionated radiation therapy), and for approximately 10-12 months following radiation therapy. Patients agreeing to participate in this study will undergo bronchoscopy for the placement of the transponders. At each radiation treatment session, patients will be localized prior to radiation delivery and tracked during radiation delivery (if patient size permits tracking) with the Calypso System.

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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.

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Title: Gut Microbiota and Radiotherapy

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Kristi Lelionis, MS, CCRP
Office: (215) 615-3273
UPCC#: 15415

Enrolled patients must plan to receive Stereotactic Body Radiotherapy (SBRT) to a lung lesion (either presumed or biopsy-proven NSCLC. This is a pilot, single arm, single center study to determine the feasibility of obtaining stool samples from adult patients receiving SBRT to a lung tumor, if SBRT induces changes in the gut microbiota and to obtain preliminary data about possible correlation of baseline composition and changes in gut microbiota with tumor response, local control, and development of pneumonitis/other side effects.

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Title: A Phase III Randomized Trial Comparing Overall Survival After Photon vs. Proton Chemoradiotherapy for Inoperable Stage II-IIIB NSCLC

Principal Investigator: Charles Simone M.D.
Coordinator: Susan Prendergast, BSN, RN
Office: (215) 662-4267
UPCC#: RTOG 1308

This randomized phase III trial studies proton chemoradiotherapy to see how well it works compared to photon chemoradiotherapy in treating patients with stage II-III non-small cell lung cancer that cannot be removed by surgery. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor, such as photon or proton beam radiation therapy, may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as paclitaxel, carboplatin, etoposide, and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether proton chemoradiotherapy is more effective than photon chemoradiotherapy in treating non-small cell lung cancer.

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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. 

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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. 

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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.

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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).

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