Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022139
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-08-10
Brief Title:
Radiation Therapy and Paclitaxel Carboplatin and Fluorouracil Followed by Esophagectomy in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Preoperative Radiation and Chemotherapy Paclitaxel Carboplatin and Continuous Infusion 5-FU for Locally Advanced Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 damage tumor cells Drugs used in chemotherapy such as paclitaxel carboplatin and fluorouracil work in different ways to stop tumor cells from dividing so they stop growing or die Giving radiation therapy with chemotherapy and giving them before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction
PURPOSE This phase II trial is studying how well giving radiation therapy together with combination chemotherapy followed by esophagectomy works in treating patients with locally advanced cancer of the esophagus or gastroesophageal junction
Detailed Description:
OBJECTIVES
Determine the pathologic complete response rate in patients with locally advanced cancer of the esophagus or gastroesophageal junction treated with radiotherapy administered concurrently with paclitaxel carboplatin and fluorouracil before esophagectomy
Determine the tolerability of this regimen in these patients
Determine the tumor response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Assess the relationship between the presence of genetic polymorphisms in these patients and the toxicity of this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42 Beginning on day 1 of chemotherapy patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes Beginning 8 weeks after surgery patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before chemotherapy on days 1 and 22 and within 2 weeks before surgery
Patients are followed every 3 months for 4 years
Determine the pathologic complete response rate in patients with locally advanced cancer of the esophagus or gastroesophageal junction treated with radiotherapy administered concurrently with paclitaxel carboplatin and fluorouracil before esophagectomy
Determine the tolerability of this regimen in these patients
Determine the tumor response rate in patients treated with this regimen
Determine the quality of life of patients treated with this regimen
Assess the relationship between the presence of genetic polymorphisms in these patients and the toxicity of this regimen
OUTLINE This is a multicenter study
Patients receive carboplatin IV and paclitaxel IV over 3 hours on days 1 and 22 and fluorouracil IV continuously on days 1-42 Beginning on day 1 of chemotherapy patients undergo radiotherapy to the esophagus 5 days a week for 5 weeks Treatment continues in the absence of disease progression or unacceptable toxicity Patients with stable or responding disease at 4-8 weeks after completion of radiotherapy undergo esophagectomy and complete dissection of the mediastinal and perigastric lymph nodes Beginning 8 weeks after surgery patients who underwent curative resection may receive a maximum of 2 additional courses of paclitaxel and carboplatin in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before chemotherapy on days 1 and 22 and within 2 weeks before surgery
Patients are followed every 3 months for 4 years
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-2012-02394 | REGISTRY | None | None |
| CDR0000068789 | REGISTRY | PDQ Physician Data Query | None |