Clinical Trials Actively Recruiting Patients With Esophageal Cancer

Study Type: Observational

Study Title: Interrogation of Wnt, Notch and Hedgehog Activity in Chemo-naive Tumors Collected During the Staging Ultrasound of Patients Diagnosed With Esophageal Cancer

Study Sponsor and Collaborators: University of Miami

Purpose: To investigate the elucidation of signaling mechanisms, control of cellular processes and discovery of small molecules that selectively target Wnt, Shh, and Notch signaling pathways that are fundamental to cancer stem or progenitor cells (CSCs).

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Percentage of samples with identifiable Notch, Wnt and Hedghog pathways in the chemo naive esophageal tumor as well as in cancer stem cell populations (CSC) (time frame: 24 months)

Principal Investigator: Anthony Capobianco, MD, University of Miami; 305-243-6308, tcapobianco@med.miami.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02221245.

Study Title: A Study of Patient-reported Outcomes in Patients With Lung or Esophageal Cancer

Study Sponsor and Collaborators: University of Virginia; Alliance for Clinical Trials in Oncology; Patient Centered Outcome Research Institute

Purpose: To determine if patient reported outcomes (using the PROMIS survey) will vary according to the presence of recurrent or metastatic lung or esophageal cancer.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Patient Reported Outcomes Measurement Information System (PROMIS) Scores (time frame: up to 30 day preoperatively for patients undergoing lung/esophageal cancer surgery through a maximum of 5 years after 1 survey is completed)

Principal Investigator: Benjamin Kozower, MD, University of Virginia. Contact: Sandra Burks, RN, 434-243-0315, sgb2c@virginia.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02239328.

Study Title: Prospective Collection of Health Information and Biospecimens in Esophageal Cancer

Study Sponsor and Collaborators: Washington University School of ­Medicine

Purpose: To create an esophageal cancer biospecimen repository that will collect, annotate, store, and distribute human esophageal cancer biospecimens.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Prospective Database (time frame: 5 years)

Principal Investigator: Varun Puri, MD, Washington University School of Medicine. Contact: Jasmine A. Lewis, BSBA; 314-362-4611; lewisja@wudosis.wustl.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01780961.

Study Type: Phase I/interventional/nonrandomized/single-group assignment

Study Title: Epigenetically-Modified Autologous Tumor Cell Vaccines With ISCOMATRIX(^TM) Adjuvant and Oral Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To assess the safety and effectiveness of tumor cell vaccines given with ISCOMATRIX and celecoxib in the treatment of lung and esophagus cancers.

Ages Eligible: 18 to 75 years

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Tabulation of patient toxicities and their grades (time frame: 30 days after last vaccine up to 25 months)

Principal Investigator: David S. Schrump, MD, National Cancer Institute; 301-496-2128, david_schrump@nih.gov.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01258868.

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

Study Sponsor and Collaborators: Abramson Cancer Center of the University of Pennsylvania

Purpose: To investigate the safety and efficacy of treating patients with esophageal cancer with concurrent preoperative proton therapy, along with carboplatin and paclitaxel.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Number of adverse events (time frame: 3 years)

Principal Investigator: John Plastaras, MD, Abramson Cancer Center of the University of Pennsylvania; 855-216-0098, PennCancerTrials@emergingmed.com.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02213497.

Study Title: Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib as Adjuvant Therapy for Lung and Esophageal Cancers, Thymic Neoplasms, Thoracic Sarcomas, and Malignant Pleural Mesotheliomas

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To evaluate the safety and effectiveness of tumor cell vaccines in combination with cyclophosphamide and celecoxib in patients with cancers involving the chest.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Tabulation of toxicity type and grade (time frame: 2 years)

Principal Investigator: David S. Schrump, MD, National Cancer Institute; 301-496-2128, david_schrump@nih.gov.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01143545.

Study Type: Phase II/interventional/single-group assignment

Study Title: A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies

Study Sponsor and Collaborators: Sidney Kimmel Comprehensive Cancer Center

Purpose: To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.

Ages Eligible: 18 to 75 years

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Prospective Database (time frame: 5 years)

Principal Investigator: Ronan Kelly, MD, Johns Hopkins University; 443-287-0005, rkelly25@jhmi@edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT02239328.

Study Title: Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

Study Sponsor and Collaborators: Cancer and Leukemia Group B; National Cancer Institute

Purpose: To study PET scan imaging in assessing response in patients with esophageal cancer receiving combination chemotherapy.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: pCR rate of PET/CT non-responders within each induction treatment group

Principal Investigator: Karyn A. Goodman, MD, Memorial Sloan Kettering Cancer Center. Contact: David H. Ilson, MD, PhD, 212-639-8895.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01333033.

Study Title: A Phase II, Multi-Center Study of Interventional Spray Cryotherapy for Early-Stage Esophageal Cancer (ICE-CANCER)

Study Sponsor and Collaborators: University of Maryland

Purpose: To evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) that are ineligible or refuse conventional therapy, including surgery, chemotherapy, radiation therapy, and endoscopic resection.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Determining the response rate to therapy (time frame: 5 years)

Principal Investigator: Bruce D. Greenwald, MD, University of Maryland; 410-328-8731, bgreenwa@medicine.umaryland.edu.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01868139.

Study Type: Phase III/interventional/randomized

Study Title: A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of Her2-Overexpressing Esophageal Adenocarcinoma

Study Sponsor and Collaborators: National Cancer Institute

Purpose: To study how well radiation therapy, paclitaxel, and carboplatin with or without trastuzumab work in treating patients with esophageal cancer.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Disease-free survival (time frame: from the date of randomization to the date of first failure or last follow-up, assessed up to 8 years)

Principal Investigator: Howard Safran, MD, NRG Oncology; 401-793-2224, hsafran@lifespan.org

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01196390.

Study Title: Phase III Randomized Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for the Treatment of Esophageal Cancer

Study Sponsor and Collaborators: MD Anderson Cancer Center

Purpose: To study how safe and effective proton-beam therapy may be in comparison to intensity modulated radiation therapy in combination with chemotherapy in patients with esophageal cancer.

Ages Eligible: 18 years and older

Genders Eligible: Both

Accepts Healthy Volunteers: No

Primary Outcome Measures: Progression-free survival (time frame: 6 weeks after radiation therapy)

Principal Investigator: Steven H. Lin, MD, PhD, MD Anderson Cancer Center; 713-563-2300.

For More Information: Visit ClinicalTrials.gov and refer to this study by its identifier: NCT01512589. ■