ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 14 of 386 for:    Recruiting, Not yet recruiting, Available Studies | "Esophageal Neoplasms"

Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02213497
Recruitment Status : Recruiting
First Posted : August 11, 2014
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

Brief Summary:
Patients with esophageal cancer to be treated with concurrent preoperative proton therapy along with carboplatin and paclitaxel.

Condition or disease Intervention/treatment Phase
Esophageal Cancer Radiation: 18F-FDG (Fluorodeoxyglucose) PET Drug: Carboplatin Drug: Paclitaxel Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Primary Purpose: Diagnostic
Official Title: Phase I Dose Escalation of Neoadjuvant Proton Beam Radiotherapy With Concurrent Chemotherapy in Locally Advanced Esophageal Cancer
Study Start Date : April 2014
Estimated Primary Completion Date : April 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of Adverse Events [ Time Frame: 3 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a histologic diagnosis of adenocarcinoma of the esophagus located distal to the carina
  • Patients with AJCC 7th edition clinical stage IIB-IIIC
  • Patient must be >18 years of age.
  • Patients must have an ECOG Performance Status of 0-1
  • Patients must be able to provide informed consent.
  • Patients must be surgical candidates with adequate hematologic, renal, hepatic and pulmonary function
  • serum AST and ALT < 2 times the upper limit of normal
  • Patients must have bilirubin < 1.5 × normal.
  • WBC > 3000/mm3, platelets > 100,000 mm3.
  • Hemoglobin > 10 g/dL serum creatinine < 1.5 times the upper limit of normal
  • Women of child-bearing potential as long as she agrees to use a recognized method of birth control (e.g. oral contraceptive, IUD, condoms or other barrier methods etc.). Hysterectomy or menopause must be clinically documented.

Exclusion Criteria:

  • Patients with primary tumors exceeding 8 cm in length or 5 cm in width ( length should be measured by endoscopic findings, width should be measured by diagnostic CT or CT portion of PET/CT)
  • Patients with primary tumors located at or above the carina
  • Prior or simultaneous malignancies within the past two years (other than cutaneous squamous or basal cell carcinoma, melanoma in situ or thyroid carcinoma)
  • Pregnant women, women planning to become pregnant and women that are nursing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213497


Contacts
Contact: John Plastaras, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: John Plastaras, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: John Plastaras, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
Principal Investigator: John Plastaras, MD Abramson Cancer Center of the University of Pennsylvania

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02213497     History of Changes
Other Study ID Numbers: UPCC 01214
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018

Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
Patients with esophageal cancer to be treated with concurrent preoperative chemoradiation with carboplatin and paclitaxel.

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Fluorodeoxyglucose F18
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Radiopharmaceuticals