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Spots Global Cancer Trial Database for Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

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Trial Identification

Brief Title: Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer

Official Title: A Randomized Study of the Efficacy and Safety of OncoGel™ Treatment as an Adjunctive Therapy to Systemic Chemotherapy and Concurrent External Beam Radiation Prior to Surgery in Subjects With Localized or Loco-regional Esophageal Cancer

Study ID: NCT00573131

Study Description

Brief Summary: OncoGel is a new experimental drug delivery system that allows the slow continuous release of paclitaxel (an approved intravenous anticancer drug), from a gel (ReGel) over a long period of time. The gel will disappear in 4 to 6 weeks as it releases the paclitaxel. The protocol is directed towards evaluating the efficacy and safety of paclitaxel delivered as a local, intralesional treatment when used in combination with chemotherapy (cisplatin and 5-FU) and radiation therapy before surgery.

Detailed Description: The primary objective of this study is to evaluate the efficacy of OncoGel given in combination with standard chemotherapy (cisplatin and 5-FU) and radiation therapy in patients with previously untreated, resectable, local or local-regional adenosarcoma or squamous cell carcinoma. All patients will receive IV cisplatin on Day 1 and Day 29 and IV 5-FU given continuously for 96 hours starting on Day 1 and Day 29. All patients will also receive out-patient radiation therapy for 28 treatments once per day for 5 1/2 weeks starting on Day 1. Patients randomized to the OncoGel treatment group will have the OncoGel dose injected into their esophageal tumors during an endoscopic procedure just before starting systemic chemotherapy and radiation therapy. All patients will have CT scans for tumor measurements before starting chemotherapy and 12 weeks later after completion of the radiation therapy and both cycles of chemotherapy. During the chemotherapy and radiation therapy, physical exams, vital signs, routine blood tests will be performed. Patients will also be asked about their quality of life and ability to swallow. In-patient surgery will be scheduled 4 to 6 weeks after completion of chemotherapy and radiation therapy. The resected esophagus and lymph nodes will be evaluated for the presence of residual tumor. Patients will be followed at months 4, 5, 6, and then every 3 Months thereafter for survival and esophageal cancer status and treatment until the last patient enrolled has completed their Month 12 visit.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

University of California San Diego, San Diego, California, United States

Rush University Medical Center, Chicago, Illinois, United States

University of Chicago Medical Center, Chicago, Illinois, United States

Indiana University Medical Center, Indianapolis, Indiana, United States

University of Kansas Medical Center, Kansas City, Kansas, United States

Thomas Jefferson University, Philadelphia, Pennsylvania, United States

Baylor University Medical Center, Dallas, Texas, United States

Digestive Health Specialists of Tyler, Texas, Tyler, Texas, United States

University Hospital Brno, Brno, , Czechia

Hospital Jablonec nad Nisou, Jablonec nad Nisou, , Czechia

University Hospital Olomouc, Olomouc, , Czechia

University Hospital Motol, Praha, , Czechia

Massaryk's Hospital in Usti nad Labem, Usti nad Labem, , Czechia

Kidwai Memorial Institute of Oncology, Bangalore, Karnataka, India

Amrita Institute of Medical Sciences, Kochi, Kerala, India

Bombay Hospital & Medical Research Centre, Mumbai, Maharashtra, India

Deenanath Mangeshkar Hospital, Erandwane, Pune, India

Meenakshi Mission Hospital and Research Centre, Madurai, Tamil Nadu, India

Samodzielny Publiczny Szpital Kliniczny, Lublin, , Poland

Samodzielnego Publicznego Szpitala Klinicznego, Szczecin, , Poland

Contact Details

Name: Kirk D Fowers, PhD

Affiliation: Boston Scientific Corporation

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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