Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00462397
Status:
UNKNOWN
Last Update Posted:
2013-08-26
First Post:
2007-04-18
Brief Title:
Paclitaxel and Carboplatin Followed by Cisplatin and Radiation Therapy in Treating Patients With Stage IB Stage II Stage III or Stage IVA Cervical Cancer
Sponsor:
University College London Hospitals
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study of Weekly Neoadjuvant Chemotherapy Followed by Radical Chemoradiation for Locally Advanced Cervical Cancer
Status:
UNKNOWN
Status Verified Date:
2007-04
Last Known Status:
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 such as paclitaxel carboplatin and 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 Giving combination chemotherapy together with radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin followed by cisplatin and radiation therapy works in treating patients with stage IB stage II stage III or stage IVA cervical cancer
PURPOSE This phase II trial is studying how well giving paclitaxel together with carboplatin followed by cisplatin and radiation therapy works in treating patients with stage IB stage II stage III or stage IVA cervical cancer
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in terms of clinical or radiologic response at 12 weeks after completion of study therapy in patients with stage IB2-IVA cervical cancer treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy
Secondary
Determine the response rate in patients treated with this neoadjuvant chemotherapy regimen
Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients
Assess the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity
Chemoradiotherapy Beginning in week 7 or as soon as blood counts recover patients receive cisplatin IV over 1 hour on day 1 Treatment repeats weekly for 4-6 courses in the absence of disease progression or unacceptable toxicity Patients also undergo concurrent radiotherapy comprising pelvic external beam radiotherapy once daily for 5½ weeks 5 weeks for patients with positive para-aortic lymph nodes and 2 applications of high-dose rate intracavitary brachytherapy or low- or medium-dose rate brachytherapy Patients with parametrial or pelvic sidewall disease extension also undergo external boost radiotherapy for 3 days
After completion of study therapy patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the response rate in terms of clinical or radiologic response at 12 weeks after completion of study therapy in patients with stage IB2-IVA cervical cancer treated with neoadjuvant chemotherapy comprising dose-dense paclitaxel and carboplatin followed by radical chemoradiotherapy comprising concurrent cisplatin and radiotherapy
Secondary
Determine the response rate in patients treated with this neoadjuvant chemotherapy regimen
Determine the toxicity of this neoadjuvant chemotherapy regimen in these patients
Assess the progression-free survival of patients treated with this regimen
Determine the overall survival of patients treated with this regimen
OUTLINE This is a multicenter study
Neoadjuvant chemotherapy Patients receive neoadjuvant chemotherapy comprising paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1 Treatment repeats weekly for up to 6 courses in the absence of disease progression or unacceptable toxicity
Chemoradiotherapy Beginning in week 7 or as soon as blood counts recover patients receive cisplatin IV over 1 hour on day 1 Treatment repeats weekly for 4-6 courses in the absence of disease progression or unacceptable toxicity Patients also undergo concurrent radiotherapy comprising pelvic external beam radiotherapy once daily for 5½ weeks 5 weeks for patients with positive para-aortic lymph nodes and 2 applications of high-dose rate intracavitary brachytherapy or low- or medium-dose rate brachytherapy Patients with parametrial or pelvic sidewall disease extension also undergo external boost radiotherapy for 3 days
After completion of study therapy patients are followed periodically for 2 years
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
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 |
|---|---|---|---|
| UCLCTC-CERVIX | None | None | None |
| UCLCTC-BRD0522-CERVIX | None | None | None |
| EUDRACT-2005-000134-20 | None | None | None |
| CRUK-BRD0522 | None | None | None |
| EU-20720 | None | None | None |