Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Endometrial Cancer

STATUS

Recruiting
End date

Apr 5, 2027
participants needed

654
sponsor

Peking University People's Hospital

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Updated on 19 February 2024

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cancer

hysterectomy

platelet count

neutrophil count

adenocarcinoma

endometrial carcinoma

chemoradiotherapy

carcinoma

endometrial adenocarcinoma

adjuvant radiotherapy

adjuvant

endometrial cancer

stage iii endometrial cancer

Summary

Show definitions

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, endometrial cancer, Uterine Cancer, Uterine Cancer, endometrial cancer
Age	100years or below
Treatment	sequential radiochemotherapy in a "sanwich" mode
Clinical Study Identifier	NCT04453904
Sponsor	Peking University People's Hospital
Last Modified on	19 February 2024

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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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Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Endometrial Cancer