Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05489848
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-08-05
First Post:
2022-08-04
Brief Title:
Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Chemotherapy Versus Chemoradiotherapy on the Prognosis for Postoperative Endometrial Cancer With P53-mutation Profile a Non-inferiority Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-08
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:
Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer stage I-IVA with p53 mutation
Detailed Description:
According to tumor molecular characteristic endometrial cancer can be divided into four types with different biological behaviors and prognosis POLE hypermutation POLEmut Mismatch repair system defect MMRd Non special molecular feature NSMP and P53 mutation p53mut For the postoperative therapy preliminary data showed that p53mut endometrial cancer was more sensitive to chemotherapy Therefore we propose a hypothesis for p53mut endometrial carcinoma compared with chemoradiotherapy postoperative chemotherapy alone had similar effects on the prognosis and similar treatment-related adverse reactions but could avoid radiotherapy-related adverse effects and reduce medical expenses And more high-quality evidence is needed to prove the hypothesis
This study were approved by the Fudan University Shanghai Cancer Center and all other institutes Before initiation of study procedures written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose
Patients will be stratified into 4 layers by surgical pathological staging FIGO 2009 preoperative and postoperative imaging evaluation surgical conditions and postoperative pathology stage IAstage IB-II stage III-IVA no residual lesion after operation any stage with maximum diameter of residual lesion 2cm except stage IVB After stratification Eligible patients in each stratification of each center will be randomly assigned 11 to receive
Arm1Paclitaxel plus carboplatin TC regimen intravenous chemotherapy Once every three weeks a total of 6 course
Arm2 Stage IA TC regimen for 4 courseVBT Stage IB-IVA no residual lesion after operation and any stage with maximum diameter of residual lesion 2cm except stage IVB TC regimen for 2 course EBRT external irradiation radiotherapy plus cisplatin concurrent chemotherapy TC regimen for 2 course same as above VBT
The specific implementation plan should be performed after NCCN2022 V1 and ESGO guidelines and adjuvant therapy is preferably started within 4-6 weeks after surgery and no later than 8 weeks after surgery
The main research indicators of this study PFS at 2 years after operation Secondary research indicators 3 years postoperative PFS and 5 years postoperative PFS and OS adverse effects quality of life medical expenses site of recurrence And expression of molecular markers Explore the correlation between the expression of molecular markers involved in IHC proteomics and molecular typing gene mutation detection of tumor tissue and therapeutic efficacy
This study is an open label randomized controlled trial with non-inferiority designStatistical analyses On the basis of data from previous studies PORTEC-3 GOG-258 GOG-249 and Molecular Classification Of G3 EEC etc the 2-year PFS of radiochemotherapy group is expected to be 75 if that in chemotherapy-alone group was 65 and abovethis group should not to be considered to be inferior and the unilateral α level is 005 80 of the detection efficiency After patient stratification in each center two groups were allocated by 11 with 15 total withdrawal groups and lost follow up rates with an expected recruitment for 5 years and 5 years of follow-up
This study were approved by the Fudan University Shanghai Cancer Center and all other institutes Before initiation of study procedures written informed consent will be obtained from each patient regarding risks of treatments and agreement of using their clinical data for research purpose
Patients will be stratified into 4 layers by surgical pathological staging FIGO 2009 preoperative and postoperative imaging evaluation surgical conditions and postoperative pathology stage IAstage IB-II stage III-IVA no residual lesion after operation any stage with maximum diameter of residual lesion 2cm except stage IVB After stratification Eligible patients in each stratification of each center will be randomly assigned 11 to receive
Arm1Paclitaxel plus carboplatin TC regimen intravenous chemotherapy Once every three weeks a total of 6 course
Arm2 Stage IA TC regimen for 4 courseVBT Stage IB-IVA no residual lesion after operation and any stage with maximum diameter of residual lesion 2cm except stage IVB TC regimen for 2 course EBRT external irradiation radiotherapy plus cisplatin concurrent chemotherapy TC regimen for 2 course same as above VBT
The specific implementation plan should be performed after NCCN2022 V1 and ESGO guidelines and adjuvant therapy is preferably started within 4-6 weeks after surgery and no later than 8 weeks after surgery
The main research indicators of this study PFS at 2 years after operation Secondary research indicators 3 years postoperative PFS and 5 years postoperative PFS and OS adverse effects quality of life medical expenses site of recurrence And expression of molecular markers Explore the correlation between the expression of molecular markers involved in IHC proteomics and molecular typing gene mutation detection of tumor tissue and therapeutic efficacy
This study is an open label randomized controlled trial with non-inferiority designStatistical analyses On the basis of data from previous studies PORTEC-3 GOG-258 GOG-249 and Molecular Classification Of G3 EEC etc the 2-year PFS of radiochemotherapy group is expected to be 75 if that in chemotherapy-alone group was 65 and abovethis group should not to be considered to be inferior and the unilateral α level is 005 80 of the detection efficiency After patient stratification in each center two groups were allocated by 11 with 15 total withdrawal groups and lost follow up rates with an expected recruitment for 5 years and 5 years of follow-up
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