Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Endometrial Cancer

  • STATUS
    Recruiting
  • End date
    Apr 24, 2027
  • participants needed
    654
  • sponsor
    Peking University People's Hospital
Updated on 24 January 2021
platelet count
cancer
hysterectomy
carcinoma
neutrophil count
adenocarcinoma
endometrial carcinoma
endometrial adenocarcinoma

Summary

Endometrial cancer is the most common gynecological malignancy affecting women's health. About 15% of the patients will have local late disease (stage III) with high risk of recurrence and tumor related mortality. There is a consensus that adjuvant radiochemotherapy is needed for stage endometrial cancer, but the best modality of radiochemotherapy is still uncertain. The retrospective data of our center showed that the sequential radiochemotherapy of "chemotherapy-radiotherapy-chemotherapy" in the "sanwich" mode could improve the survival outcome in patients with advanced endometrial cancer. A multicenter, prospective, randomized controlled study to compare the "sanwich" mode of radiochemotherapy and the "concurrent chemoradiotherapy followed by chemotherapy" mode will be carried out to determine the better modality of radiochemotherapy in stage III endometrial adenocarcinoma.

Details
Condition Endometrial Carcinoma, Uterine Cancer, Endometrial Cancer
Treatment sequential radiochemotherapy in a "sanwich" mode
Clinical Study IdentifierNCT04453904
SponsorPeking University People's Hospital
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

patients of primary treatment
All patients must have undertaken comprehensive staging operationSurgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging)
Patients with endometrial adenocarcinoma confirmed by postoperative patholog
All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria
Entry into the study is limited to no more than 8 weeks from the date of surgery
Patients with adequate organ function, reflected by the following parameters
WBC Normal value of the institution
Absolute neutrophil count (ANC) Normal value of the institution
Platelet count 100,000/mcl
SGOT, SGPT, and alkaline phosphatase 1.25 X upper limit of normal (ULN)
Bilirubin 1.5 X ULN
Creatinine institutional ULN
Patients with a Karnofsky score60
The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up

Exclusion Criteria

Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy)
Patients with residual tumor after surgery
Patients with other invasive malignancies
Patients with contraindications of radiotherapy and chemotherapy (with a history of myocardial infarction within 3 month, unstable angina pectoris or history of uncontrolled arrhythmia s from the date of registration) and who cannot receive postoperative adjuvant radiotherapy and chemotherapy
Patients with an estimated survival of less than 6 months
Those who are unable or unwilling to comply with the research requirements
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