A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer

• Status: Recruiting
• Trial end date: 2025-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Cisplatin

Criteria

Inclusion Criteria:

• Patients with pathological diagnosed cervical cancer and treated with radical resection

• Stage I-II diseases (FIGO system ver. 2014)

• Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months

• Pelvic MRI or CT indicate existence of lymphocyst

• Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria)

Exclusion Criteria:

• Patients with distant metastasis before or during radiotherapy

• Severe dysfunction of heart, lung, liver, kidney or hematopoietic system

• Severe neurological, mental or endocrine diseases

• History of other malignancies

• Prior chemotherapy, radiotherapy or application of monoclonal antibodies

• Patients participated in clinical trials of other drugs within last 3 months

• Pregnant or lactating women

• Those who are considered by the researchers unsuitable to participate