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
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
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.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Overall tumor response at the primary tumor site based on measurement of primary tumor volume (excluding involved lymph nodes) by spiral CT
Screening and Week 12
Kirk D Fowers, PhD
United States: Food and Drug Administration
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|
|Baylor University Medical Center||Dallas, Texas 75246|
|University of California San Diego||La Jolla, California 92093|
|University of Chicago Medical Center||Chicago, Illinois 60637|
|Thomas Jefferson University||Philadelphia, Pennsylvania 19107-6541|
|Indiana University Medical Center||Indianapolis, Indiana 46202|
|Digestive Health Specialists of Tyler, Texas||Tyler, Texas 75701|