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

NCT05489848 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2022-08-05

No results posted yet for this study

Summary

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

Conditions

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Yulan Ren · Fudan University

  • Huaying Wang · Fudan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-20
Primary Completion
2028-08-20
Completion
2030-08-20

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05489848 on ClinicalTrials.gov