Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003379
Status:
COMPLETED
Last Update Posted:
2013-05-27
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Paclitaxel and Cisplatin in Treating Patients With Cervical Cancer
Sponsor:
Gynecologic Oncology Group
Organization:
GOG Foundation
Study Overview
Official Title:
A Phase III Study Of Whole Pelvic Radiation Therapy With Concomitant Paclitaxel and Cisplatin Chemotherapy in Patients With Cervical Carcinoma Stages I-IV Limited to the Pelvis
Status:
COMPLETED
Status Verified Date:
2004-11
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 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 Phase III trial to study the effectiveness of radiation therapy to the pelvis plus paclitaxel and cisplatin in treating patients who have cervical cancer
PURPOSE Phase III trial to study the effectiveness of radiation therapy to the pelvis plus paclitaxel and cisplatin in treating patients who have cervical cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as radiosensitization in patients with stage IB2 IIA IIB IIIB or IVA invasive carcinoma of the cervix
Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus radiotherapy in these patients
Determine the effects of this regimen at the maximum tolerated dose on progression-free survival and overall survival in these patients
Determine the site of local or distant recurrence in these patients after treatment with this regimen
OUTLINE This is a dose escalation study of paclitaxel
Patients undergo external beam radiotherapy RT to the pelvic region 5 days a week during weeks 1-5 Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin concurrently with pelvic field radiotherapy on days 1 8 15 22 29 and 36 Patients undergo low-dose rate LDR OR high-dose rate HDR brachytherapy For patients undergoing LDR brachytherapy intracavitary implants are inserted 1 or 2 times within 3 weeks after completion of external beam RT For patients undergoing HDR brachytherapy intracavitary implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT Patients may receive a parametrial boost
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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at the MTD as above
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or at time of recurrence until death
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3-7 years
Determine the toxicity of radiotherapy plus paclitaxel and cisplatin used as radiosensitization in patients with stage IB2 IIA IIB IIIB or IVA invasive carcinoma of the cervix
Determine the maximum tolerated dose of paclitaxel when combined with cisplatin plus radiotherapy in these patients
Determine the effects of this regimen at the maximum tolerated dose on progression-free survival and overall survival in these patients
Determine the site of local or distant recurrence in these patients after treatment with this regimen
OUTLINE This is a dose escalation study of paclitaxel
Patients undergo external beam radiotherapy RT to the pelvic region 5 days a week during weeks 1-5 Patients receive paclitaxel IV over 1 hour immediately followed by cisplatin concurrently with pelvic field radiotherapy on days 1 8 15 22 29 and 36 Patients undergo low-dose rate LDR OR high-dose rate HDR brachytherapy For patients undergoing LDR brachytherapy intracavitary implants are inserted 1 or 2 times within 3 weeks after completion of external beam RT For patients undergoing HDR brachytherapy intracavitary implants are inserted once a week for 5 weeks beginning during week 4 of external beam RT Patients may receive a parametrial boost
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 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are accrued and treated at the MTD as above
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter or at time of recurrence until death
PROJECTED ACCRUAL A total of 20-40 patients will be accrued for this study within 3-7 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GOG-9803 | None | None | None |