Ignite Creation Date:
2024-05-05 @ 4:48 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00316862
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2006-04-19
Brief Title:
Cisplatin Irinotecan and Radiation Therapy in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer That Can Be Removed By Surgery
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Trial of Preoperative Irinotecan Cisplatin and Radiation in Esophageal Cancer
Status:
COMPLETED
Status Verified Date:
2018-04
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:
This phase II trial studies how well giving cisplatin and irinotecan hydrochloride together with radiation therapy works in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery Drugs used in chemotherapy such as cisplatin and irinotecan hydrochloride 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 Giving combination chemotherapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
Detailed Description:
PRIMARY OBJECTIVES
I To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan irinotecan hydrochloride followed by concurrent cisplatinirinotecan and radiation therapy
SECONDARY OBJECTIVES
I To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography PET scan
II To evaluate the toxicity and tolerability of therapy including surgical morbidity and mortality
III To determine the overall survival disease free survival and pattern of failure
OUTLINE
INDUCTION CHEMOTHERAPY COURSES 1-2 Patients receive cisplatin intravenously IV over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
CHEMORADIOTHERAPY COURSES 3-4 Beginning 2 weeks after completion of induction chemotherapy patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
SURGERY Approximately 4-8 weeks after completion of chemoradiotherapy patients undergo surgery to remove the tumor
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 years
I To determine the pathologic complete response rate in patients with surgically resectable esophageal cancer treated pre-operatively with induction chemotherapy with weekly cisplatin and irinotecan irinotecan hydrochloride followed by concurrent cisplatinirinotecan and radiation therapy
SECONDARY OBJECTIVES
I To evaluate potential response or progression of disease during induction chemotherapy with positron emission tomography PET scan
II To evaluate the toxicity and tolerability of therapy including surgical morbidity and mortality
III To determine the overall survival disease free survival and pattern of failure
OUTLINE
INDUCTION CHEMOTHERAPY COURSES 1-2 Patients receive cisplatin intravenously IV over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 of courses 1 and 2 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
CHEMORADIOTHERAPY COURSES 3-4 Beginning 2 weeks after completion of induction chemotherapy patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 1 and 8 of courses 3 and 4 and undergo radiotherapy daily 5 days a week in course 3 Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity
SURGERY Approximately 4-8 weeks after completion of chemoradiotherapy patients undergo surgery to remove the tumor
After completion of study treatment patients are followed up every 3 months for 2 years and then every 6 months for 3 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 |
|---|---|---|---|
| U10CA180821 | NIH | NCI Clinical Trial Reporting Program | httpsreporternihgovquickSearchU10CA180821 |
| CDR0000468495 | REGISTRY | None | None |
| NCI-2009-00491 | REGISTRY | None | None |