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NOT YET RECRUITING
NCT05489848
PHASE2/PHASE3

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

Sponsor: Fudan University

View on ClinicalTrials.gov

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

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.