Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04789941
Status:
UNKNOWN
Last Update Posted:
2021-03-10
First Post:
2020-11-28
Brief Title:
How To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Phase II Trial To Evaluate The Efficiency And Safety Of Neoadjuvant Chemotherapy In Locally Advanced Cancer Cervix
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_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:
1 This strategy might suggest a therapeutic option to preserve ovarian function in young patients among which locally advanced cancer cervix is common Based on previous studies neoadjuvant irinotecan and cisplatin followed by radical hysterectomy and adjuvant chemotherapy has the potential to improve the prognosis compared the concurrent chemo-radiotherapyCCRT
2 To offer an alternative effective treatment line replacing concurrent chemo-radiotherapy to avoid dramatic radiotherapy induced complications which might impede a safe successful surgery
2- To reduce the proportion of patients who will go for radiotherapy consequently those patients will still have a chance of probable less complicated surgery in case of local recurrence
3- This study will involve neo-adjuvant chemotherapy NACT in treating patients with stage II-III cervical cancer for reducing tumor size minimizing blood loss during surgery and eradication of possible micro-metastasis
4- To Improve the likelihood of achieving complete tumor resection after NACT 5- Investigators will further follow-up those patients for more detailed assessments to confirm whether NACT can improve patients prognoses survival quality of life and the standard of care
2 To offer an alternative effective treatment line replacing concurrent chemo-radiotherapy to avoid dramatic radiotherapy induced complications which might impede a safe successful surgery
2- To reduce the proportion of patients who will go for radiotherapy consequently those patients will still have a chance of probable less complicated surgery in case of local recurrence
3- This study will involve neo-adjuvant chemotherapy NACT in treating patients with stage II-III cervical cancer for reducing tumor size minimizing blood loss during surgery and eradication of possible micro-metastasis
4- To Improve the likelihood of achieving complete tumor resection after NACT 5- Investigators will further follow-up those patients for more detailed assessments to confirm whether NACT can improve patients prognoses survival quality of life and the standard of care
Detailed Description:
Treatments for locally advanced cervical cancer defined as International Federation of Gynecology and Obstetrics FIGO stage Ib2-III include primary surgery neoadjuvant chemotherapy and concurrent chemo-radiotherapy CCRT In many countries CCRT is accepted as the standard therapy for such tumors However each of these therapies has both advantages and disadvantages however more recently it has been given using neoadjuvant chemotherapy with intravenous irinotecan hydrochloride CPT-11 and cisplatin DNA topoisomerases are enzymes that regulate and control DNA topology Topoisomerase 1 catalyzes the transient cutting of a single DNA strand the passage of another DNA strand through the break and then resealing of the DNA break Camptothecin CPT an antitumor alkaloid isolated from Camptotheca acuminata interferes with DNA topoisomerase 1 function Cisplatin cis-dichlorodiammineplatinums II is a first generation platinum compound Platinum-based NACT followed by radical hysterectomy has been proposed as an alternative approach to radiotherapy or CCRT in locally advanced cervical cancer especially of squamous cell histology with objective response rates ranging from 694 to 902 pathological optimal response rates ranging from 213 to 483 5-year disease free survival DFS rates ranging from 554 to 71 and 5-year overall survivalOS rates ranging from 589 to 81 respectively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None