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Chemotherapy vs Chemoradiotherapy for Post-operative Endometrial Cancer Patients With P53-mutation
Sponsor: Fudan University
Summary
Aim to compare chemotherapy alone or chemoradiotherapy for post-operative endometrial cancer (stage I-IVA) with p53 mutation.
Official title: Chemotherapy Versus Chemoradiotherapy on the Prognosis for Postoperative Endometrial Cancer With P53-mutation Profile: a Non-inferiority Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2022-08-20
Completion Date
2030-08-20
Last Updated
2022-08-05
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Cisplatin
Concurrent cisplatin intravenous chemotherapy on radiotherapy days 1 and 29,50mg / m2, a total of 2 times.
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.
VBT
Subnormal vaginal mucosa was 0.5cm, 30Gy / 5times /5weeks.