Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448643
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2007-03-15
Brief Title:
Whole-Abdominal Radiation Therapy and Cisplatin in Treating Patients With Stage III or Stage IV Endometrial Cancer That Has Been Removed by Surgery
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
A Phase I Study Using Abdominal Radiotherapy as a Cisplatin Chemosensitizer for Optimally Debulked Stage IIIIV Carcinoma of the Endometrium
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 Drugs used in chemotherapy such as 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 Radiation therapy may also make tumor cells more sensitive to cisplatin Giving radiation therapy together with cisplatin after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery
PURPOSE This phase I trial is studying the side effects and best dose of whole-abdominal radiation therapy when given together with cisplatin in treating patients with stage III or stage IV endometrial cancer that has been removed by surgery
Detailed Description:
OBJECTIVES
Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium
OUTLINE This is a dose-escalation study of whole-abdominal radiotherapy WAR
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV Beginning within 6 weeks after completion of standard chemotherapy patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1 Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose RPTD is determined The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the RPTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Determine a recommended phase II dose of adjuvant whole-abdominal radiotherapy when administered with cisplatin in patients with optimally debulked stage III or IV carcinoma of the endometrium
OUTLINE This is a dose-escalation study of whole-abdominal radiotherapy WAR
Patients receive 3 courses of standard chemotherapy comprising carboplatin IV and paclitaxel IV Beginning within 6 weeks after completion of standard chemotherapy patients receive cisplatin IV over 30-60 minutes and undergo a single fraction of WAR on day 1 Treatment with cisplatin and WAR repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients may undergo standard vaginal brachytherapy beginning no earlier than the last course of standard chemotherapy or no later than 1 week before the start of cisplatin and WAR
Cohorts of 3-6 patients receive escalating doses of WAR until the recommended phase II dose RPTD is determined The RPTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity At least 6 patients are treated at the RPTD
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 30 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 |
|---|---|---|---|
| WIRB-20050721 | None | None | None |
| SCCC-2001064 | None | None | None |