Comparing two methods of radiotherapy and chemotherapy for stage III endometrial cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness of two different modalities of adjuvant radiochemotherapy for patients with stage III endometrial cancer. It will compare a sequential 'sandwich' approach of chemotherapy followed by radiotherapy and then chemotherapy again against a concurrent chemoradiotherapy followed by chemotherapy. The goal is to determine which method provides better survival outcomes for patients with advanced endometrial adenocarcinoma. The study will be conducted as a multicenter, prospective, randomized controlled trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. patients of primary treatment
2. All patients must have undertaken comprehensive staging operation（Surgery must have included a hysterectomy and bilateral salpingooophorectomy and surgical staging).
3. Patients with endometrial adenocarcinoma confirmed by postoperative patholog.
4. All patients with Surgical Stage III endometrial carcinoma according to FIGO 2009 staging criteria.
5. Entry into the study is limited to no more than 8 weeks from the date of surgery.
6. Patients with adequate organ function, reflected by the following parameters:

   1. WBC ≥ Normal value of the institution;
   2. Absolute neutrophil count (ANC) ≥ Normal value of the institution;
   3. Platelet count ≥ 100,000/mcl;
   4. SGOT, SGPT, and alkaline phosphatase ≤ 1.25 X upper limit of normal (ULN) ;
   5. Bilirubin ≤ 1.5 X ULN;
   6. Creatinine ≤ institutional ULN.
7. Patients with a Karnofsky score≥60.
8. The patients should voluntarily join the study, sign an approved informed consent with good compliance and cooperation with the follow-up.

Exclusion Criteria:

1. Patients who have received prior adjuvant therapy (radiotherapy or chemotherapy or endocrine therapy).
2. Patients with residual tumor after surgery.
3. Patients with other invasive malignancies.
4. 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.
5. Patients with an estimated survival of less than 6 months.
6. Those who are unable or unwilling to comply with the research requirements

Where it's running

• Jianliu Wang
  Beijing, Beijing Municipality, China Recruiting

Study contacts

• Study coordinator: Guo Zhang, Ph.D
• Email: zhangguo-2005@163.com
• Phone: +861088324381

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.