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

PHASE2/PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

294

Participants

Timeline

Start Date

August 20, 2022

Primary Completion Date

August 20, 2028

Study Completion Date

August 20, 2030

Conditions
Endometrial Cancer
Interventions
DRUG

Paclitaxel

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.

DRUG

Carboplatin

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.

DRUG

Cisplatin

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

RADIATION

EBRT

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.

RADIATION

VBT

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

All Listed Sponsors
lead

Fudan University

OTHER

NCT05489848 - Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation | Biotech Hunter | Biotech Hunter