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Modified Tumor-free Techniques Operation to Cervical Cancer

NCT06836869RecruitingNAINTERVENTIONAL

Summary

The goal of this clinical trial is to learn if laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) works to treat FIGO stage IB2 cervical cancer as good as abdominal radical hysterectomy (ARH). It will also learn about the safety of LRH-MTF. The main questions it aims to answer are: Does LRH-MTF achieve a non-inferior disease-free survival rate at 4.5 years post - operation compared to ARH? What complications do patients have during and after the operation when receiving LRH-MTF? Researchers will compare LRH-MTF to ARH to see if LRH-MTF works no worse than ARH in treating FIGO stage IB2 cervical cancer. Participants will: 1. Undergo either LRH-MTF or ARH as assigned by randomization. 2. Visit the hospital for follow-up according to the study schedule for various examinations including blood tests, imaging studies, and assessment of complications. 3. Complete quality-of-life questionnaires such as EORTC QLQ-C30, QLQ-CX24, FSFI, and FSDS-R at baseline (pre-operation) and specific time points during the follow - up period (post-operation 6 months, 1 year, 2 years, 3 years, 4.5 years).

Key Facts

Lead Sponsor

Peking Union Medical College Hospital

Enrollment

524

Start Date

2025-02-20

Completion Date

2032-07-01

Study Type

INTERVENTIONAL

Official Title

A Multicenter, Non-inferiority Trial to Compare the Effectiveness and Safety of Laparoscopic Radical Hysterectomy Incorporating Modified Tumor-free Techniques Versus Abdominal Radical Hysterectomy in Patients With Stage IB2 Cervical Cancer

Interventions

Laparoscopic radical hysterectomy incorporating modified tumor-free techniquesAbdominal radical hysterectomy

Conditions

Cervical Cancer Stage IB2

Eligibility

Age Range

18 Years – 65 Years

Sex

FEMALE

1. Inclusion Criteria:

1.1 Females aged 18 to 65 years old. 1.2 Histologically confirmed primary cervical squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

1.3 FIGO 2018 stage IB2. 1.4 The maximum diameter of the cervical lesion measured by MRI is \>2 cm and ≤4 cm. For those with MRI contraindications, PET/CT, CT, or ultrasound can be used as alternatives.

1.5 Scheduled to receive type C (Q - M classification) radical hysterectomy. 1.6 Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

1.7 Willing to participate in this trial and sign the informed consent form. 1.8 Able to cooperate and complete follow - up and relevant examinations. 1.9 For pre - menopausal women, a negative pregnancy test within 30 days before surgery.

1.10 Laboratory test indicators of vital organs meet the standards
2. Exclusion Criteria:

2.1 Special pathological types (gastric - type adenocarcinoma, neuroendocrine carcinoma, clear cell carcinoma, carcinosarcoma, etc.).

2.2 Imaging examinations suggest pelvic or para - aortic lymph node metastasis (MRI or CT shows a short - axis diameter of ≥1.5 cm, or SUV ≥2.5), or histopathology indicates lymph node metastasis.

2.3 History of pelvic and abdominal radiotherapy. 2.4 History of neoadjuvant chemotherapy. 2.5 Uterus larger than that at 10 weeks of pregnancy. 2.6 Contraindications for surgery and anesthesia (such as severe medical comorbidities).

2.7 Patients who cannot tolerate the Trendelenburg position. 2.8 Patients who cannot cooperate with treatment and follow - up. 2.9 Pregnant patients. 2.10 History of other malignancies, except for those who have been cancer - free for more than 3 years with no current evidence of tumor recurrence.

Outcome Measures

Primary Outcomes

4.5-year Disease-free Survival

The time from the surgery until the first recurrence or death from any cause within 4.5 years after surgery. Recurrence needs to be confirmed by histopathology and/or imaging. If pathological evidence cannot be obtained, recurrence should be determined by two or more detection methods, and adjudicated by an independent Endpoint Event Evaluation Committee.

Time frame: From the surgery to the 4.5 years after the end of treatment

Secondary Outcomes

4.5-year Overall Survival

The time interval from the surgery to death from any cause within 4.5 years after surgery.

Time frame: From the surgery to the 4.5 years after the end of treatment

Pattern of Reccurence

According to the location of the first recurrence, it is divided into intra-pelvic recurrence and distant recurrence. Analyze the differences in the location of tumor recurrence after different surgical methods to provide a reference for subsequent treatment and prognosis judgment.

Time frame: From surgery to the 4.5 years after the end of treatment

Estimated surgical blood loss

Calculate it as the difference in the weight of gauze/gauze pads before and after the surgery (g) divided by 1.05, plus the difference between the total volume of aspirated fluid and the volume of irrigation fluid at the end of the surgery (mL). Also, record whether blood transfusion is performed during the surgery and within 1 week after the surgery. In addition, record the changes in hemoglobin before and after the surgery to assess blood loss. Perform a complete blood count (hemoglobin) test within 1 week before the surgery and on the 1st day after the surgery.

Time frame: From the start to the end of the surgery up to 24 hours

Operating time

The time from making the first incision to completing the suturing.

Time frame: From the start to the end of the surgery up to 24 hours

Postoperative pain

It is evaluated using the Visual Analogue Scale (VAS). Additionally, the types, quantities, and administration methods of postoperative analgesics are recorded.

Time frame: From surgery to the third day after surgery

Gastrointestinal function recovery

Record the time (in hours) of the first postoperative flatus.

Time frame: From the end of surgery to the first postoperative flatus at 7 days.

Length of hospital stay

The number of days from hospitalization to discharge.

Time frame: From hospitalization to discharge up to 90 days.

Treatment cost

The total cost of hospitalization and outpatient services related to this disease. Conduct cost - effectiveness analysis through incremental cost, improvement of functional outcomes, and quality - adjusted life - years.