A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
- Determine the activity of gefitinib, in terms of median survival and distant metastatic
disease control, in patients treated with neoadjuvant and adjuvant cisplatin,
fluorouracil, and radiotherapy who are undergoing surgery for esophageal and
gastroesophageal junction cancer.
- Determine the pathologic complete and partial response rate in patients treated with
- Determine the toxicity of this regimen in these patients and in patients who are
disease free and receiving long-term maintenance gefitinib.
- Preoperative regimen: Patients undergo radiotherapy twice a day during days 1-12 (for a
total of 10 treatment days). Patients receive fluorouracil IV continuously and
cisplatin IV continuously on days 1-4. Patients also receive oral gefitinib once daily
on days 1-28. At 6 weeks, patients with locoregionally confined disease undergo
surgical resection and then proceed to the postoperative regimen. Patients with a
medical contraindication to surgery proceed directly to the postoperative regimen.
- Postoperative regimen: Beginning 4-10 weeks after surgery or 6 weeks after completing
the first course of therapy, patients undergo radiotherapy and receive fluorouracil and
cisplatin as in the preoperative regimen.
- Maintenance regimen: Patients receive oral gefitinib beginning on day 1 of the
postoperative regimen and continuing for 2 years in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Survival at 1 year
Survival at 1 year
David J. Adelstein, MD
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
United States: Food and Drug Administration
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Cleveland, Ohio 44195|