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

PHASE2TerminatedINTERVENTIONAL
Enrollment

137

Participants

Timeline

Start Date

January 31, 2008

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Esophageal CancerAdenocarcinoma of the EsophagusSquamous Cell Carcinoma
Interventions
DRUG

OncoGel (Paclitaxel gel)

6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy

DRUG

cisplatin

75 mg/m2 IV (in the vein) once on Day 1 and Day 29

DRUG

5-FU

1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29

RADIATION

radiation therapy

50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks

PROCEDURE

esophageal resection

Removal of esophagus after completion of chemotherapy and radiation therapy

Trial Locations (20)

19107

Thomas Jefferson University, Philadelphia

46202

Indiana University Medical Center, Indianapolis

60612

Rush University Medical Center, Chicago

60637

University of Chicago Medical Center, Chicago

62500

University Hospital Brno, Brno

66160

University of Kansas Medical Center, Kansas City

75246

Baylor University Medical Center, Dallas

75701

Digestive Health Specialists of Tyler, Texas, Tyler

92093

University of California San Diego, San Diego

400020

Bombay Hospital & Medical Research Centre, Mumbai

411004

Deenanath Mangeshkar Hospital, Erandwane

560029

Kidwai Memorial Institute of Oncology, Bangalore

625107

Meenakshi Mission Hospital and Research Centre, Madurai

682026

Amrita Institute of Medical Sciences, Kochi

466 60

Hospital Jablonec nad Nisou, Jablonec nad Nisou

775 20

University Hospital Olomouc, Olomouc

150 06

University Hospital Motol, Prague

401 13

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

20-081

Samodzielny Publiczny Szpital Kliniczny, Lublin

70-111

Samodzielnego Publicznego Szpitala Klinicznego, Szczecin

Sponsors
All Listed Sponsors
lead

Boston Scientific Corporation

INDUSTRY

NCT00573131 - Efficacy and Safety of OncoGel™ Added to Chemotherapy and Radiation Before Surgery in Subjects With Esophageal Cancer | Biotech Hunter | Biotech Hunter