Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation

Endometrial Cancer Clinical Trial

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

Clinical Trial Summary

Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.

Clinical Trial 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 IA,stage 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 (1:1) to receive:

Arm1:Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks, a total of 6 course.

Arm2: Stage IA: TC regimen for 4 course+VBT. 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 NCCN(2022 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 design.Statistical 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 above,this group should not to be considered to be inferior, and the unilateral α level is 0.05, 80% of the detection efficiency. After patient stratification in each center, two groups were allocated by 1:1, with 15% total withdrawal groups and lost follow up rates, with an expected recruitment for 5 years and 5 years of follow-up. ;

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

• NCT number: NCT05489848
• Study type: Interventional
• Source: Fudan University
• Contact: Yulan Ren
• Phone: 18017312918
• Email: yulan_ren@shca.org.cn
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: August 20, 2022
• Completion date: August 20, 2030