Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00160875
Status:
COMPLETED
Last Update Posted:
2017-05-04
First Post:
2005-09-08
Brief Title:
Pre-operative Chemo CPT11 Cisplatin Radiotherapy Plus Surgery for Resectable Esophageal Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase II Study to Assess the Efficacy of Combined Pre-operative Chemo CPT11 Cisplatin Radiotherapy External Beam Brachytherapy Plus Surgery for Potentially Resectable Thoracic Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Cancer of the esophagus is a very serious cancer Studies have shown that using chemotherapy and radiation before surgery is the most promising treatment approach with one quarter to one half of tumors shrinking by 50 or more in size after chemotherapy and radiation In patients who have a very good response to this treatment survival following esophagectomy has increased although the amount of increase has varied quite a bit between the different studies Older studies have used the drugs Cisplatin and 5-fluoruracil Although this combination of drugs has been beneficial we wish to use a newer combination of drugs which may be more effective for esophageal cancer The chemotherapy drugs used in this study are Cisplatin and Irinotecan We also want to find out what side effects these drugs cause when given with radiation and how often these side effects occur
Detailed Description:
Historical surgical series have reported that the chance of cure with surgery alone is approximately one in four Many phase II studies and some phase III studies have examined the role of induction preoperative chemotherapy and radiation In general these studies have demonstrated a trend to improved survival using an induction regimen with one phase III study reporting a significant improvement in survival Two meta-analyses have failed to demonstrate a clear advantage of an induction regimen
When these trials are reviewed it is apparent that there is a subgroup of patients who are found at the time of resection to have had a complete pathological response to their treatment and these patients clearly experience improved survival
These previous trials have used older chemotherapy agents Nevertheless cisplatin remains one of the most active drugs available for treating solid tumours Irinotecan is a newer drug that has demonstrated significant activity in colorectal cancer and more recently in esophageal cancer A previous single institution trial of cisplatin and irinotecan in esophageal cancer demonstrated a significant response and acceptable toxicity
By giving one cycle of chemotherapy alone first it is expected that the dysphagia usually experienced by these patients will improve sufficiently and that nutritional support ie feeding tube will not be required as has been demonstrated in a previous study of this drug combination The same drugs will then be given concurrently with external beam radiation in order to take advantage of the radiosensitizing properties of both these drugs
This will be followed by a boost dose of radiation which will provide a total dose in the tumourcidal range Surgery will follow the boost dose of radiation
This study proposes to combine two drugs with demonstrated activity in esophageal cancer cisplatin and Irinotecan with radiation prior to surgery with the hypothesis that these more active agents will offer better control of distant metastatic disease Their radiosensitizing properties when combined with radiation will improve local control and provide an increased rate of pathological complete response in patients with surgically resectable esophageal cancer
When these trials are reviewed it is apparent that there is a subgroup of patients who are found at the time of resection to have had a complete pathological response to their treatment and these patients clearly experience improved survival
These previous trials have used older chemotherapy agents Nevertheless cisplatin remains one of the most active drugs available for treating solid tumours Irinotecan is a newer drug that has demonstrated significant activity in colorectal cancer and more recently in esophageal cancer A previous single institution trial of cisplatin and irinotecan in esophageal cancer demonstrated a significant response and acceptable toxicity
By giving one cycle of chemotherapy alone first it is expected that the dysphagia usually experienced by these patients will improve sufficiently and that nutritional support ie feeding tube will not be required as has been demonstrated in a previous study of this drug combination The same drugs will then be given concurrently with external beam radiation in order to take advantage of the radiosensitizing properties of both these drugs
This will be followed by a boost dose of radiation which will provide a total dose in the tumourcidal range Surgery will follow the boost dose of radiation
This study proposes to combine two drugs with demonstrated activity in esophageal cancer cisplatin and Irinotecan with radiation prior to surgery with the hypothesis that these more active agents will offer better control of distant metastatic disease Their radiosensitizing properties when combined with radiation will improve local control and provide an increased rate of pathological complete response in patients with surgically resectable esophageal cancer
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