Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Cisplatin

Tubulin Modulators

Antimitotic Agents

Paclitaxel plus carboplatin (TC) regimen, intravenous chemotherapy. Once every three weeks with total of 6 cycles.

Stage IA: TC(Paclitaxel plus carboplatin) regimen for 4 course+/-VBT.

Stage IB-II ( with no residual disease): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.

Stage III-IVA ( with no residual disease) and any stage except IVB (residual disease \<2cm): TC regimen for 2 course +EBRT (external irradiation radiotherapy) plus cisplatin concurrent chemotherapy +TC regimen for 2 course ±VBT.

Radiotherapy can be started 3 weeks after the completion of the chemotherapy, and Chemotherapy can be started 2 - 3 weeks after the completion of radiotherapy.

Paclitaxel: paclitaxel dose of 135\~175mg / m2, about 3 hours after the infusion, the use of pretreatment drugs before the infusion according to the drug instructions. Every 21 days is one session.

Carboplatin: Doses were given at AUC=5 - 6 and used after paclitaxel. Based on the calculated amount, the maximum dose of carboplatin per chemotherapy does not exceed 750mg.

Concurrent cisplatin intravenous chemotherapy on radiotherapy days 1 and 29,50mg / m2, a total of 2 times.

50.4Gy/28 / 6 weeks; common iliac node positive or paraaortic node positive plus extended field.The radiation extension field should include the entire pelvic cavity, the common iliac vessels and the paraaortic lymph node area.The range above the extension field is determined based on the clinical status, but at least 1-2cm above the renal vascular level.

EBRT

Subnormal vaginal mucosa was 0.5cm, 30Gy / 5times /5weeks.

Yulan Ren

Huaying Wang

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

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.

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

Chemotherapy Versus Chemoradiotherapy on the Prognosis for Postoperative Endometrial Cancer With P53-mutation Profile: a Non-inferiority Randomized Controlled Trial

Adverse events related with intervention. Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0 will be recorded, as well as incidence of adverse events.

Collect the questionnaire ETRTC-QLQ-C30 V3.0-EN, and count scores change through intervention (Chemotherapy or Radiochemotherapy)

Medical expenses refer to all kinds of expenses incurred by patients in order to treat diseases. It includes not only the medical expenses and surgical expenses of doctors, but also the expenses of hospitalization, nursing, hospital equipment, etc.

The frequency of recurrence site in different groups.

The percentage of patients who have first relapse within 2 years after surgery.

The percentage of patients who have first relapse within 3 years after surgery.

The percentage of patients who have first relapse within 5 years after surgery. The percentage of patients who died within 5 years after surgery.

Spots Global Cancer Trial Database for vbt

Every month we try and update this database with for vbt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for vbt

Every month we try and update this database with for vbt cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for vbt cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.