Clinical trial NCT00573131
Conditions: Esophageal Cancer Adenocarcinoma of the Esophagus Squamous Cell Carcinoma
Keywords: Esophageal cancer Localized esophageal cancer Operable esophageal cancer Loco-regional esophageal cancer Esophagectomy Phase 2 Paclitaxel Tumor Local Chemotherapy radiation therapy surgery OncoGel Squamous cell carcinoma of the esophagus
Sponsor: Boston Scientific Corporation
Start date: 2008-01-01; Completion date: 2010-11-01
Enrollment: 137 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

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.

Arms: arm 1: OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection. arm 2: Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
Interventions: intervention 1: OncoGel (Paclitaxel gel) intervention 2: cisplatin intervention 3: 5-FU intervention 4: radiation therapy intervention 5: esophageal resection
Intervention descriptions: intervention 1: 6.3 mg/mL tumor volume, injected into the esophagus during endoscopy, once, before starting chemoradiotherapy intervention 2: 75 mg/m2 IV (in the vein) once on Day 1 and Day 29 intervention 3: 1000 mg/m2/day, IV (in the vein) for 4 days (96 hours) for two cycles starting on Day 1 and Day 29 intervention 4: 50.4 Gy, given in 28 treatments, once per day for 5 1/2 weeks intervention 5: Removal of esophagus after completion of chemotherapy and radiation therapy

Protocol documents: