Ignite Creation Date:
2024-05-05 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072033
Status:
COMPLETED
Last Update Posted:
2012-06-05
First Post:
2003-11-04
Brief Title:
Neoadjuvant Docetaxel and Cisplatin Plus Chemoradiotherapy Followed By Surgery in Treating Patients With Locally Advanced Resectable Esophageal Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Docetaxel and Cisplatin Chemo- and Radiochemotherapy Followed by Surgery in Patients With 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 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 Giving combination chemotherapy with radiation therapy before surgery may shrink the tumor so that it can be removed
PURPOSE This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced resectable esophageal cancer
PURPOSE This phase II trial is studying how well giving docetaxel and cisplatin together with chemoradiotherapy followed by surgery works in treating patients with locally advanced resectable esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery in terms of pathological response rate in patients with locally advanced resectable esophageal cancer
Determine the feasibility of this regimen in terms of successful completion of therapy and survival at 30 days postoperatively in these patients
Secondary
Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results
Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the clinical benefit of this regimen in these patients
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22
Chemoradiotherapy Beginning 21 days after the last dose of neoadjuvant chemotherapy patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks
Surgery Patients undergo surgery 3-8 weeks after the final administration of radiotherapy
Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline day 22 of chemotherapy day 1 of chemoradiotherapy before surgery and then every 3 months for 1 year
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 22-66 patients will be accrued for this study
Primary
Determine the effectiveness of neoadjuvant docetaxel and cisplatin and chemoradiotherapy followed by surgery in terms of pathological response rate in patients with locally advanced resectable esophageal cancer
Determine the feasibility of this regimen in terms of successful completion of therapy and survival at 30 days postoperatively in these patients
Secondary
Determine the parameters of disease control in these patients and toxicity of this regimen and compare these parameters with published results
Correlate early improvement of dysphasia after 1-2 courses of chemotherapy with predictive value with regard to tumor response and long-term disease control in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Determine the clinical benefit of this regimen in these patients
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on days 1 and 22
Chemoradiotherapy Beginning 21 days after the last dose of neoadjuvant chemotherapy patients receive docetaxel IV over 30 minutes and cisplatin IV over 1 hour once a week and undergo radiotherapy 5 days a week for 5 weeks
Surgery Patients undergo surgery 3-8 weeks after the final administration of radiotherapy
Treatment continues in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline day 22 of chemotherapy day 1 of chemoradiotherapy before surgery and then every 3 months for 1 year
Patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL Approximately 22-66 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-20323 | None | None | None |