Modified Tumor-free Techniques Operation to Cervical Cancer
- Conditions
- Cervical Cancer Stage IB2
- Registration Number
- NCT06836869
- Lead Sponsor
- Peking Union Medical College Hospital
- Brief 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).
- Detailed Description
A progress report will be conducted within 4 weeks after all participants have completed their 6-month postoperative visit (the 5th visit). The report will be performed by an independent third-party statistical team, which will provide a comprehensive analysis of the safety data, baseline characteristic, and perioperative indicators.
The study will perform one final analysis.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 524
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.
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 4.5-year Disease-free Survival From enrollment to the 4.5 years after the end of treatment The time from randomization 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.
- Secondary Outcome Measures
Name Time Method 4.5-year Overall Survival From enrollment to the 4.5 years after the end of treatment The time interval from randomization to death from any cause within 4.5 years after surgery.
Operating time From the start to the end of the surgery up to 24 hours The time from making the first incision to completing the suturing.
Postoperative pain From surgery to the third day after surgery It is evaluated using the Visual Analogue Scale (VAS). Additionally, the types, quantities, and administration methods of postoperative analgesics are recorded.
Gastrointestinal function recovery From the end of surgery to the first postoperative flatus at 7 days. Record the time (in hours) of the first postoperative flatus.
Length of hospital stay From hospitalization to discharge up to 90 days. The number of days from hospitalization to discharge.
Pattern of Reccurence From surgery to the 4.5 years after the end of treatment 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.
Estimated surgical blood loss From the start to the end of the surgery up to 24 hours 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.
Treatment cost From enrollment to the 4.5 years after the end of treatment 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.
EORTC QLQ - C30 scale From enrollment to the 4.5 years after the end of treatment EORTC QLQ - C30 is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30. Each of the 15 subscales of the EORTC QLQ - C30 is scored from 0 to 100.
For the functional scales (physical, role, emotional, cognitive, and social functioning), higher scores indicate better functioning and thus a better outcome. For the symptom scales (fatigue, nausea and vomiting, pain, etc.) and the global health status/QOL scale, a higher score on the symptom scales means more severe symptoms (a worse outcome), while a higher score on the global health status/QOL scale means a better quality of life. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.EORTC QLQ - CX24 Scale From enrollment to the 4.5 years after the end of treatment EORTC QLQ - CX24 Scale is short for European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Cervical Cancer Module. Similar to the QLQ - C30, most of its subscales are scored from 0 to 100. Interpretation of Scores: The interpretation is generally in line with the QLQ - C30. Higher scores in functional aspects indicate better conditions, while higher scores in symptom-related aspects indicate more severe symptoms or worse outcomes. It is used to evaluate the quality of life at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
FSFI Scale From enrollment to the 4.5 years after the end of treatment FSFI is short for Female Sexual Function Index. Minimum and Maximum Values: The total score of the FSFI ranges from 2 to 36. Interpretation of Scores: A higher score indicates better female sexual function and a better outcome in terms of sexual health. Scores below a certain threshold may indicate sexual dysfunction.
It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.FSDS - R Scale From enrollment to the 4.5 years after the end of treatment FSDS - R Scale is short for Female Sexual Distress Scale - Revised. Minimum and Maximum Values: The FSDS - R typically has a score range from 0 to 52.
Interpretation of Scores: In this scale, a higher score indicates a higher level of sexual distress, meaning a worse outcome. It reflects the degree of distress a woman experiences related to her sexual function or situation.
It is used to evaluate the sexual function at baseline (pre - operation) and at 6 months, 1 year, 2 years, 3 years and 4.5 years after surgery.
Related Research Topics
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Trial Locations
- Locations (13)
Tianjin Central Hospital of Gynecology Obstetrics
🇨🇳Tianjin, China
The First Hospital of Lanzhou University
🇨🇳Lanzhou, Gansu, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Cangzhou Central Hospital
🇨🇳Cangzhou, Hebei, China
The Fourth Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Hunan Provincial Maternal and Child Health Care Hospital
🇨🇳Changsha, Hunan, China
The Second Hospital of Jilin University
🇨🇳Changchun, Jilin, China
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
🇨🇳Shanghai, Shanghai, China
The Fourth Military Medical University, Xijing Hospital
🇨🇳Xi'an, Shanxi, China
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
🇨🇳Xianyang, Shanxi, China
Affiliated Hospital of North Sichuan Medical College
🇨🇳Nanchong, Sichuan, China
Zhejiang cancer hospital
🇨🇳Hangzhou, Zhejiang, China
Peking Union Medical College Hospital
🇨🇳Beijing, China