Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00008112
Status:
UNKNOWN
Last Update Posted:
2013-08-07
First Post:
2001-01-06
Brief Title:
Cisplatin Combined With Radiation Therapy and Hyperthermia in Treating Patients With Stage II Stage III or Stage IV Cervical Cancer
Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Feasibility Study of the Combination of Radiotherapy Chemotherapy and Hyperthermia for the Treatment of Stage IIB-III-IVA Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2002-10
Last Known Status:
ACTIVE_NOT_RECRUITING
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 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 Hyperthermia therapy kills tumor cells by heating them to several degrees above body temperature Combining hyperthermia with radiation therapy and chemotherapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II stage III or stage IV cervical cancer
PURPOSE Phase II trial to study the effectiveness of cisplatin combined with radiation therapy and hyperthermia in treating patients who have stage II stage III or stage IV cervical cancer
Detailed Description:
OBJECTIVES
Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer
Determine the acute toxicity of this regimen in these patients
Determine the complete response rate of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo external beam radiotherapy EBRT once daily 5 days a week for 5 weeks On 1 day of each week patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT During week 6 patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy Treatment continues in the absence of unacceptable toxicity
Patients are followed at 6-8 weeks every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 6-34 patients will be accrued for this study
Determine the feasibility of adding cisplatin and locoregional hyperthermia to external beam and intracavity radiotherapy in patients with stage IIB-IVA cervical cancer
Determine the acute toxicity of this regimen in these patients
Determine the complete response rate of patients treated with this regimen
OUTLINE This is a multicenter study
Patients undergo external beam radiotherapy EBRT once daily 5 days a week for 5 weeks On 1 day of each week patients also receive cisplatin IV over 3 hours and hyperthermia over 90 minutes beginning 1-6 hours after completion of EBRT During week 6 patients receive hyperthermia and cisplatin on the day before the 1 day of intracavity radiotherapy Treatment continues in the absence of unacceptable toxicity
Patients are followed at 6-8 weeks every 3 months for 3 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 6-34 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-20036 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000068376 | REGISTRY | None | None |