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

A Multicenter Randomized Controlled Study of Modalities of Adjuvant Radiotherapy and Chemotherapy for Stage Ⅲ Endometrial Cancer

This study is testing which treatment method—chemotherapy followed by radiotherapy or both together—works better for people with stage III endometrial cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 654 (estimated)
• Sex: Female
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT04453904 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include patients who have undergone comprehensive staging surgery for primary treatment of stage III endometrial adenocarcinoma.

Not a fit: Patients with non-adenocarcinoma types of endometrial cancer or those who have not had the required surgical staging may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved survival rates for patients with stage III endometrial cancer.

How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific comparison is novel.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality

• Jianliu Wang — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Guo Zhang, Ph.D

Conditions Endometrial Cancer; radiochemotherapy; sanwich mode