Ignite Creation Date:
2024-05-05 @ 9:04 PM
Last Modification Date:
2024-10-26 @ 9:58 AM
Study NCT ID:
NCT00806117
Status:
UNKNOWN
Last Update Posted:
2019-07-30
First Post:
2008-12-08
Brief Title:
Comparison of Different Subsequent Treatments After Radical Surgery
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma
Status:
UNKNOWN
Status Verified Date:
2019-07
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:
STARS
Brief Summary:
Cervical cancer is still the most common gynecologic cancer There was no obvious increase of the survival over years The risk of recurrence after radical surgery has increased with positive lymph nodes positive surgical margins positive lymphatic vascular space and deep invasion of the cervical stroma In recent years the role of chemotherapy for cervical cancer has been gradually recognized But as a adjuvant therapy post-surgery if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive
In this study in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors nine hundred and ninety patients will be randomly divided into three groups comparing radiotherapy alone concurrent chemoradiation and sequence chemotherapy and radiotherapy 2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors To guide clinical treatment options
In this study in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors nine hundred and ninety patients will be randomly divided into three groups comparing radiotherapy alone concurrent chemoradiation and sequence chemotherapy and radiotherapy 2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors To guide clinical treatment options
Detailed Description:
After radical surgery patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited lymph node metastases LNM positive parametrium or margins PPM lymphatic vascular space involvement LVSI deep invasion of cervical stromal DIS Eligible patients were randomized to three groups Group A underwent 50 GY RT alone Group B received concurrent weekly cisplatin and RT Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT followed by two cycles
We have recruited 800 patients till November 2014
We have recruited 800 patients till November 2014
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