Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00238407
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2005-10-12
Brief Title:
Docetaxel Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Cannot Be Removed By Surgery
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Docetaxel and Cisplatin Chemotherapy Followed by Radiochemotherapy in Patients With Inoperable Locally Advanced Esophageal Cancer A Multicenter Phase II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 such as docetaxel and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Docetaxel and cisplatin may also make tumor cells more sensitive to radiation therapy Giving docetaxel and cisplatin together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving docetaxel and cisplatin together with radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the local tumor-control rate in patients with locally advanced unresectable esophageal cancer treated with docetaxel cisplatin and radiotherapy
Secondary
Determine the feasibility of this regimen in these patients
Determine the adverse reactions of this regimen in these patients
Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine the long-term survival rate in patients treated with this regimen
Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen
Determine quality of life and clinical benefit in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1 22 43 50 57 64 and 71 Beginning on day 43 week 7 of chemotherapy patients undergo radiotherapy once daily 5 days a week for 7 weeks
Quality of life is assessed at baseline at day 22 and 43 during treatment and then every 3 months for 1 year after completion of study treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 46 patients will be accrued for this study
Primary
Determine the local tumor-control rate in patients with locally advanced unresectable esophageal cancer treated with docetaxel cisplatin and radiotherapy
Secondary
Determine the feasibility of this regimen in these patients
Determine the adverse reactions of this regimen in these patients
Determine local- and distant-failure and time to local- and distant-failure in patients treated with this regimen
Determine overall survival of patients treated with this regimen
Determine the long-term survival rate in patients treated with this regimen
Determine whether early improvement of dysphagia is a predictive marker in patients treated with this regimen
Determine quality of life and clinical benefit in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive docetaxel IV over 30-60 minutes and cisplatin IV over 1 hour on days 1 22 43 50 57 64 and 71 Beginning on day 43 week 7 of chemotherapy patients undergo radiotherapy once daily 5 days a week for 7 weeks
Quality of life is assessed at baseline at day 22 and 43 during treatment and then every 3 months for 1 year after completion of study treatment
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 46 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 |
|---|---|---|---|
| EU-20529 | None | None | None |