Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00258323
Status:
COMPLETED
Last Update Posted:
2015-09-30
First Post:
2005-11-22
Brief Title:
RadiotherapyChemotherapyBefore and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells Drugs used in chemotherapy such as cisplatin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving these treatments after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer
PURPOSE This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer
Detailed Description:
OBJECTIVES
Primary
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
Secondary
Determine the pathologic complete and partial response rate in patients treated with this regimen
Determine the toxicity of this regimen in these patients and in patients who are disease free and receiving long-term maintenance gefitinib
OUTLINE
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
Primary
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
Secondary
Determine the pathologic complete and partial response rate in patients treated with this regimen
Determine the toxicity of this regimen in these patients and in patients who are disease free and receiving long-term maintenance gefitinib
OUTLINE
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZENECA-1839US0233 | Other Identifier | Cleveland Clinic IRB | httpsreporternihgovquickSearchP30CA043703 |
| CCF-5848 | OTHER | None | None |
| P30CA043703 | NIH | None | None |