Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Advanced or Metastatic Cancer of the Esophagus

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

March 31, 1997

Primary Completion Date

May 31, 2006

Study Completion Date

January 31, 2007

Conditions
Esophageal Cancer
Interventions
DRUG

cisplatin

Cisplatin will be given at a dose of 100 mg/m2 at a concentration of 1 mg/ml over one hour on Day 1 and 29 for a total of 2 courses

DRUG

fluorouracil

5-FU will be given at 500 mg/m2 in 1 liter D5 1/2 by continuous infusion every 12 hours for a total of 8 doses (Total 1.0 g/m2/day X 4 days) on Days 1-4 and 29-32 for a total of 2 courses

DRUG

paclitaxel

30 mg/m2 - 45 mg/m2 given weekly. The dose each subject receives will depend on when they enter the study

PROCEDURE

surgical procedure

Surgical resection should take place approximately 4 weeks following completion of the chemotherapy.

RADIATION

radiation therapy

The dose of radiation to the tumor and nodal area will be 4500 cGy given as 180 cGy fractions daily, Monday through Friday, for 5 weeks

Trial Locations (1)

27599-7295

Lineberger Comprehensive Cancer Center, UNC, Chapel Hill

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

UNC Lineberger Comprehensive Cancer Center

OTHER