Perelman School of Medicine at the University of Pennsylvania

Clinical Research | Gastrointestinal Cancers

Strategic Direction and Overarching Themes for the Service

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

  • The impact of high-dose radiotherapy on local control and survival in esophageal and pancreatic cancer
  • The nexus of immunotherapy and radiation in pancreatic cancer
  • The use of proton therapy to reduce side effects and escalate radiation dose in a number of disease sites, including esophageal cancer, pancreatic cancer and anal cancer
  • Exploring the role of proton therapy and SBRT in hepatocellular carcinoma.

Description of Programs and Protocols within the Service

Title: Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy with Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

Principal Investigator: John P. Plastaras, M.D., Ph.D.
Coordinator: Ashley Feriozzi
Office: (215) 615-3272
UPCC#: 01214

This Phase I trial seeks to identify the maximally tolerated radiation dose (MTD) of dose-escalated proton radiotherapy in combination with carboplatin/paclitaxel for esophageal cancer.  Patients who are 18 years of age or holder with a diagnosis of adenocarcinoma of the esophagus are eligible to participate. Patients on study will receive chemoradiation for 5 weeks followed by surgery 4-8 weeks after. Radiation therapy dose will be escalated to determine the MTD.   Patients on study will have the option of participating in two ancillary studies which include blood draws for analysis of CTCs and a FDG PET imaging Scan. These are being done to assess their utility of use as a treatment response predictor for chemoradiation. Patients will be on study for up to 16 weeks.

Title: A Phase I Dual Dose Escalation Study of Radiation and Nab-Paclitaxel in Patients with Unresectable and Borderline Resectable Pancreatic Cancer

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Dana Patsch
Office: (215) 615-5645
UPCC#: 32213

The rationale for this trial is based on a number of recent discoveries in the field of pancreatic cancer:

  1. In some patients, local control (rather than distant metastases) seems to be the dominant clinical problem and the determinant of survival.
  2. Intensification of local therapy with radiation dose escalation has been shown to improve local control and survival in a phase 2 trial.
  3. Nab-paclitaxel (Abraxane) is a promising new drug in pancreatic cancer and preliminary data indicate that it may be a better, more specific, radiosensitizer that those currently in use (5FU and gemcitabine).

We hypothesize that local therapy intensification with radiation dose escalation and pancreatic cancer-targeted radiosensitization with nab-paclitaxel will improve local control and survival in patients with unresectable or borderline resectable pancreatic cancer.

In this clinical trial we will also examine the role of a number of novel biomarkers as predictors of response to the study treatment. These include SPARC, caveolin-1, circulating tumor cells and SMAD4.

Title: A Pilot Study to Evaluate Radiotherapy-Induced Anti-Tumor Immunity in Metastatic Carcinoma of the Pancreas (details)

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Sally McNulty, R.N.
Office: (215) 662-7720
UPCC#: 14213

Recent evidence suggests that radiotherapy can induce immune response in a number of malignancies, and that this systemic effect may be exploited and augmented with a number of immune modulators to improve cancer control. In this clinical trial, we are characterizing the immune response induced by radiotherapy in patients with metastatic pancreatic cancer.

Title: A Pilot Randomized Trial of Transarterial Chemoembolization (TACE) with or without Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma (HCC) Patients Awaiting Liver Transplantation (details)

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Sally McNulty, R.N.
Office: (215) 662-7720
UPCC#: 16213

Liver transplant is the best treatment for HCC in patients with advanced cirrhosis, but dropout rates from the waiting list are significant, ranging from 10-20% for tumor progression. “Bridging” therapies such as TACE are used to delay HCC progression and keep patients within transplant criteria

Stereotactic Body Radiation Therapy (SBRT) is a powerful new method of treating liver metastasis. Recent data suggests that it may be useful in HCC as well. The goal of this trial is to find if the addition of SBRT to TACE in patients with HCC awaiting liver transplantation will improve local control and allow more patients to remain on the transplant list.

Title: A Phase II Randomized Trial Evaluating the Addition of High or Standard Intensity Radiation to Gemcitabine and NAB-Paclitaxel for Locally Advanced Pancreatic Cancer

Principal Investigator: Edgar Ben-Josef, M.D.
Coordinator: Susan Prendergast, BSN, RN
Office: (215) 662-4267
UPCC#: RTOG 1201

This randomized phase II trial studies how well high or standard intensity radiochemotherapy after gemcitabine hydrochloride and paclitaxel albumin-stabilized nanoparticle formulation (nab-paclitaxel) work compared with gemcitabine hydrochloride and nab-paclitaxel alone in treating patients with pancreatic cancer that cannot be removed by surgery. Drugs used in chemotherapy, such as gemcitabine hydrochloride and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing or by stopping them from spreading. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs, such as capecitabine, may make tumor cells more sensitive to radiation therapy. Giving radiation therapy in different ways and adding chemotherapy may kill more tumor cells. It is not yet known whether high intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel is more effective than standard intensity radiochemotherapy after gemcitabine hydrochloride and nab-paclitaxel or gemcitabine hydrochloride and nab-paclitaxel alone in treating pancreatic cancer.

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 Service Members

John P. Plastaras, M.D., Ph.D. (PubMed)
Edgar Ben-Josef, M.D. (PubMed)
William Levin, M.D.



© The Trustees of the University of Pennsylvania || Site best viewed in a supported browser. || Site Design: PMACS Web Team