PFL-Alpha Chemotherapy Followed by Surgery or FHX for Early Stage Esophageal Cancer - A Pilot Project
OBJECTIVES: I. Determine response rates, duration of response, and performance status in
patients with stage I-III esophageal cancer after treatment with cisplatin, fluorouracil,
interferon alfa, and leucovorin calcium. II. Determine toxicities of this regimen in these
patients. III. Determine relapse and survival rates in this patient population treated with
this regimen. IV. Determine response rates, duration of response, performance status, and
relapse and survival rates for inoperable candidates in this patient population treated with
this regimen followed by radiotherapy. V. Determine the toxicities of this regimen followed
by radiotherapy in these patients. VI. Evaluate recurrence following this treatment regimen
in this patient population. VII. Compare roentgenographic and ultrasound responses to
histopathologic responses with this regimen in this patient population. VIII. Evaluate the
effects of this regimen and its relation to the ability to achieve negative surgical margins
and evaluate the extent of multifocality, nodal disease, tumor size, and tumor grade. IX.
Determine the incidence of perioperative complications following this regimen, including
surgical as well as operative time, blood loss, perioperative transfusions, and length of
hospital stay.
OUTLINE: Patients receive leucovorin calcium IV continuously on days 1-5.5, interferon alfa
subcutaneously daily on days 1-6, cisplatin IV over 6 hours on day 1, and fluorouracil IV
continuously on days 1-5. Treatment continues every 21 days for 3 courses in the absence of
unacceptable toxicity. Approximately 4 weeks after chemotherapy, esophagectomy is performed
in patients without evidence of locally advanced unresectable esophageal cancer or distant
metastases. Patients determined to have residual disease following esophagectomy will be
considered for radiotherapy. Patients not undergoing esophagectomy receive chemoradiotherapy
21-28 days after completion of initial chemotherapy. Patients receive oral hydroxyurea every
12 hours on days 0-5 and fluorouracil IV continuously on days 1-5. Patients undergo
radiotherapy to esophagus daily on days 1-5. Treatment continues every 14 days for 7 courses
in the absence of unacceptable toxicity. Patients are followed every 6 months for 2 years.
PROJECTED ACCRUAL: Approximately 15-45 patients will be accrued for this study.
Interventional
Primary Purpose: Treatment
Claudia Tellez, MD
Study Chair
Hematology-Oncology Associates of Illinois
United States: Federal Government
NU 94I1
NCT00004897
October 1999
November 2007
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center, Northwestern University | Chicago, Illinois 60611 |