Status:
RECRUITING
Modality of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer
Lead Sponsor:
Peking University People's Hospital
Conditions:
Endometrial Cancer
Eligibility:
FEMALE
Phase:
NA
Brief 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 relat...
Eligibility Criteria
Inclusion
- patients of primary treatment
- All patients must have undertaken comprehensive staging operation（Surgery 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 score≥60.
- The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.
Exclusion
- 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
Key Trial Info
Start Date :
May 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2027
Estimated Enrollment :
654 Patients enrolled
Trial Details
Trial ID
NCT04453904
Start Date
May 12 2020
End Date
April 1 2027
Last Update
July 1 2020
Active Locations (1)
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1
Jianliu Wang
Beijing, Beijing Municipality, China, 100044