Cervical Cancer Stage IB2
Conditions
Keywords
radical hysterectomy, Modified Tumor-Free Techniques, cervical cancer, FIGO stage 1B2, laparotomy, laparoscopic surgery
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.
Interventions
PROCEDURELaparoscopic radical hysterectomy incorporating modified tumor-free techniques
Thoroughly examine the pelvic and abdominal cavities. Coagulation of the fallopian tubes are recommanded at the beginning of the surgery. The use of uterine manipulator is prohibited. An "8"-suture at the uterine fundus is recommended. Insert a trocar 3 cm above the pubic symphysis and suspend the uterus by pulling with a needle holder. Alternative methods are also acceptable. Perform pelvic lymphadenectomy. Conduct radical hysterectomy according to the Q-M classification type C. Before incising the vagina, the upper part of the vagina must be closed (using a cable tie or suture), or the vagina can be incised transvaginally after deflating the pneumoperitoneum. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity. The vaginal stump can be sutured either laparoscopically or transvaginally.
PROCEDUREAbdominal radical hysterectomy
At the onset of surgery, comprehensively explore the pelvic and abdominal cavities. If intraperitoneal metastases are identified, radical hysterectomy should be aborted. Perform pelvic lymphadenectomy. After lymph node resection, remove the lymph nodes from the surgical field promptly. Sentinel lymph node mapping and biopsy are not performed in this study. Perform radical hysterectomy according to type C of the Q-M classification. It can be accompanied by or without bilateral salpingo - oophorectomy. For patients who retain their ovaries, bilateral ovarian transposition can be carried out. Before incising the vagina, close the upper segment of the vagina and/or the vaginal stump. This can be achieved using instruments such as a large right - angle clamp or an auricular clamp. Sterilized distilled water or saline solution (≥1000 mL) is used to irrigate the pelvic cavity.
Sponsors
Peking Union Medical College Hospital
Hebei Medical University Fourth Hospital
Second Hospital of Jilin University
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Cangzhou Central Hospital
Zhejiang Cancer Hospital
Hunan Provincial Maternal and Child Health Care Hospital
LanZhou University
RenJi Hospital
The Fourth Military Medical University, Xijing Hospital
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Affiliated Hospital of North Sichuan Medical College
Tianjin Central Hospital of Gynecology Obstetrics
Southwest Hospital, China
Obstetrics & Gynecology Hospital of Fudan University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sichuan Cancer Hospital and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, multi-center, open-label, blind endpoint evaluation (PROBE), non-inferiority, randomized controlled trial with a parallel-group design. The main hypothesis of this study is that laparoscopic radical hysterectomy incorporating modified tumor-free techniques (LRH-MTF) is non-inferior to abdominal radical hysterectomy (ARH) in terms of disease-free survival at 4.5 years post-operation. A non-inferiority margin of 7% is set based on previous studies. This means that as long as the difference in the 4.5-year disease-free survival rate between LRH-MTF and ARH is within this non-inferiority margin, LRH-MTF will be considered non-inferior to ARH. If LRH-MTF meets this criterion, it can potentially offer the advantages of minimally invasive surgery, such as reduced surgical trauma, shorter hospital stay, and faster recovery, while maintaining comparable oncological outcomes.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 4.5-year Disease-free Survival | From the surgery to the 4.5 years after the end of treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 4.5-year Overall Survival | From the surgery to the 4.5 years after the end of treatment | The time interval from the surgery to death from any cause within 4.5 years after surgery. |
| 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. |
| 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. |
| 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. |
Countries
China
Contacts
CONTACTYuan Li, professor
Outcome results
None listed