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An Open-Label, Prospective, Multicenter, Randomized Controlled Trial of Hysterectomy with Endometrial Resection for Early Cervical Cancer (Stages IB1, IB2, IIA1)

An Open-Label, Prospective, Multicenter, Randomized Controlled Trial of Hysterectomy with Endometrial Resection for Early Cervical Cancer (Stages IB1, IB2, IIA1)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129009
Enrollment
Unknown
Registered
2026-07-29
Start date
2026-08-15
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical cancer stages IB1, IB2, and IIA1, including squamous cell carcinoma of the cervix, adenocarcinoma of the cervix, or adenosquamous carcinoma of the cervix.

Interventions

Experimental group:total Müllerian duct compartment resection
Control group:Traditional Radical Hysterectomy

Sponsors

The second hospital of Dalian Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient voluntarily participates in this study and signs the informed consent form; 2. Aged 18 to 75 years old; 3. Based on auxiliary examinations, preoperative diagnosis is cervical cancer stages IB1, IB2, or IIA1 [FIGO 2018]; 4. Pathologically confirmed as cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; 5. Preoperative imaging (MRI, CT, PET-CT) shows no definite parametrial invasion (i.e., not stage IIB) and no evidence of lymph node metastasis; 6. No prior history of radiotherapy or chemotherapy; 7. ECOG score 0–1; 8. Expected survival over 6 months; 9. Women of childbearing age must have a negative pregnancy test (serum or urine) within 7 days before enrollment and agree to use appropriate contraception during the study; 10. According to the investigator, there are no absolute surgical contraindications, the patient can tolerate surgery, and can comply with the study protocol.

Exclusion criteria

Exclusion criteria: 1.Preoperative imaging (MRI, CT, PET-CT) indicates suspected lymph node metastasis, parametrial invasion, or distant metastasis; 2.Pathology confirms specific histological types, such as neuroendocrine tumors, serous carcinoma, gastric-type adenocarcinoma, clear cell carcinoma, or endometrioid adenocarcinoma; 3.Previous radiotherapy for pelvic malignancies; 4.History of partial hysterectomy or radical hysterectomy; 5.Active or uncontrolled severe infection; 6.Liver cirrhosis or decompensated liver disease; 7.Chronic renal insufficiency or renal failure; 8.Myocardial infarction, severe arrhythmia, and congestive heart failure = Grade 2 (New York Heart Association [NYHA] classification); 9.Patients with concurrent other malignancies requiring treatment and/or newly diagnosed malignancies within the past 5 years; 10.History of immunodeficiency, including HIV-positive status or other acquired or congenital immunodeficiency disorders; 11.Patients who have undergone pelvic artery embolization; 12.Patients with concomitant conditions requiring treatment with drugs that significantly impair hepatic or renal function, such as tuberculosis; 13.Patients unable to understand the study content, unable to cooperate, or refusing to sign the informed consent form; 14.Patients with concomitant diseases or other special circumstances that pose a serious threat to patient safety or interfere with study completion.

Design outcomes

Primary

MeasureTime frame
3-year progression-free survival rate;

Secondary

MeasureTime frame
5-year overall survival rate;Incidence of Perioperative Complications;

Countries

China

Contacts

Public ContactJun Wang

The second hospital of Dalian Medical University

wj202fck@163.com+86 411 8467 1291

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026