Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003377
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
1999-11-01
Brief Title:
Radiation Therapy Paclitaxel and Cisplatin in Treating Patients With Cancer of the Cervix
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase I Study of Extended Field Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients Cervical Carcinoma Metastatic to the Para-Aortic Lymph Nodes
Status:
COMPLETED
Status Verified Date:
2012-12
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 Radiation therapy uses high-energy x-rays to damage tumor cells Paclitaxel and cisplatin may increase the effectiveness of radiation therapy by making the tumor cells more sensitive to the radiation Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen
PURPOSE This phase III trial is studying the side effects and best dose of paclitaxel when given with radiation therapy and cisplatin and to see how well they work in treating patients with cancer of the cervix that has spread to the lymph nodes in the pelvis and abdomen
Detailed Description:
OBJECTIVES
Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy as radiation sensitization in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes
Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population
Determine the effect of this treatment regimen on progression-free survival overall survival and site of recurrence local vs distant in these patients
OUTLINE This is a multicenter dose-escalation study of paclitaxel
Patients receive external beam radiotherapy RT to the para-aortic nodes and the pelvis daily for 5 weeks RT must be completed within 8 weeks of its initiation During or after external beam RT intracavitary radiation is administered 1-5 times Concurrently with external beam RT patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1 8 15 22 29 and 36
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or until the time of recurrence or death
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4 years
Determine the toxicity of extended field radiotherapy with concurrent paclitaxel and cisplatin chemotherapy as radiation sensitization in patients with previously untreated carcinoma of the cervix metastatic to the para-aortic lymph nodes
Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus extended field radiotherapy in this patient population
Determine the effect of this treatment regimen on progression-free survival overall survival and site of recurrence local vs distant in these patients
OUTLINE This is a multicenter dose-escalation study of paclitaxel
Patients receive external beam radiotherapy RT to the para-aortic nodes and the pelvis daily for 5 weeks RT must be completed within 8 weeks of its initiation During or after external beam RT intracavitary radiation is administered 1-5 times Concurrently with external beam RT patients receive paclitaxel IV over 1 hour followed immediately by cisplatin IV on days 1 8 15 22 29 and 36
Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 6 patients experience dose-limiting toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or until the time of recurrence or death
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| GOG-9804 | None | None | None |