Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003087
Status:
COMPLETED
Last Update Posted:
2013-06-25
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Radiation Therapy and Surgery in Treating Patients With Cancer of the Esophagus
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Preoperative Combined Modality Therapy for Localized Esophageal Carcinoma Cisplatin-Paclitaxel Followed by Radiation Therapy With Concurrent Cisplatin and Paclitaxel
Status:
COMPLETED
Status Verified Date:
2013-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Radiation therapy uses high-energy x-rays to damage tumor cells Combining more than one drug with radiation therapy before surgery may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and surgery in treating patients with cancer of the esophagus that can be surgically removed
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy radiation therapy and surgery in treating patients with cancer of the esophagus that can be surgically removed
Detailed Description:
OBJECTIVES I Determine the response rate to preoperative induction paclitaxelcisplatin followed by concurrent paclitaxelcisplatin and radiotherapy in locally advanced esophageal cancer II Determine the toxic effects including surgical morbidity and mortality and patient survival after this combination therapy III Monitor the quality of life of patients receiving this combination therapy IV Determine c Jun oncogene and thymidylate synthase expression and p53 mutation before and after this combination therapy
OUTLINE This is an open label multicenter study Adenocarcinoma stratum closed Patients receive of induction chemotherapy consisting of paclitaxel IV over 3 hours followed by cisplatin IV on days 1 and 22 Patients then receive radiation therapy 5 days a week for 6 weeks along with paclitaxel and cisplatin 4 days a week Patients undergo surgery complete or partial resection within 4-8 weeks of completion of the chemoradiotherapy Patients are followed every 3 months for the first 2 years every 6 months for the next 2 years and annually thereafter Quality of life is assessed for the first year of follow up only
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for each histology adenocarcinoma squamous carcinoma within 18-24 months Adenocarcinoma stratum closed
OUTLINE This is an open label multicenter study Adenocarcinoma stratum closed Patients receive of induction chemotherapy consisting of paclitaxel IV over 3 hours followed by cisplatin IV on days 1 and 22 Patients then receive radiation therapy 5 days a week for 6 weeks along with paclitaxel and cisplatin 4 days a week Patients undergo surgery complete or partial resection within 4-8 weeks of completion of the chemoradiotherapy Patients are followed every 3 months for the first 2 years every 6 months for the next 2 years and annually thereafter Quality of life is assessed for the first year of follow up only
PROJECTED ACCRUAL A maximum of 25 patients will be accrued for each histology adenocarcinoma squamous carcinoma within 18-24 months Adenocarcinoma stratum closed
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 |
|---|---|---|---|
| NCI-T97-0066 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000065787 | REGISTRY | None | None |