Ignite Creation Date:
2024-05-05 @ 6:37 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510250
Status:
COMPLETED
Last Update Posted:
2015-07-27
First Post:
2007-07-31
Brief Title:
A Phase III Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
A Phase III Study of Cisplatin and Radiation in Combination With Sorafenib in Cervical Cancer
Status:
COMPLETED
Status Verified Date:
2015-07
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 will be a multi-institution single-arm open-label phase III trial Eligible patients will have pathologically-proven T1b-3b N01 M0 epithelial carcinoma of the cervix We hypothesize that sorafenib in combination with chemotherapy and radiotherapy may have anti-tumor activity in patients with cervical cancer Sorafenib has not previously been combined with conventional RT-CT to treat cervix cancer
Detailed Description:
During the phase I component of the study low risk patients tumor size 5 cm and radiographically node negative will receive sorafenib alone in escalating doses for at least 1 week prior to the start of conventional treatment with radiotherapy and chemotherapy RT-CT High risk patients tumor 5 cm or node positive will receive sorafenib alone in escalating dose for at least 1 week prior to the start of RT-CT as well as concurrently with RT-CT Cohorts of 3 patients per dose level are planned If 13 patients encounters a dose-limiting toxicity DLT then that cohort will be expanded to 6 patients If 23 of patients encounter a DLT then that dose level will be declared as the maximum tolerated dose MTD An additional 3 patients will be entered into the dose level one below the MTD The recommended phase II dose RPTD is defined as the dose level with 16 patients with DLT
For the phase II component all patients will receive sorafenib at the RPTD for at least 1 week prior to and concurrent with RT-CT
For the phase II component all patients will receive sorafenib at the RPTD for at least 1 week prior to and concurrent with RT-CT
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 |
|---|---|---|---|
| Bayer Protocol 12138 | None | None | None |