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Modified Tumor-free Techniques Operation to Cervical Cancer

RecruitingNAAges 18 Years - 65 YearsFemalePeking Union Medical College Hospital
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค4 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 โ‰ฅ1.5 cm, or SUV โ‰ฅ2.5), 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.
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What it tests

  • Laparoscopic radical hysterectomy incorporating modified tumor-free techniques
  • Abdominal radical hysterectomy
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Where

17 sites
The First Hospital of Lanzhou University
Lanzhou, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, China
Cangzhou Central Hospital
Cangzhou, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, China
Hunan Provincial Maternal and Child Health Care Hospital
Changsha, China
The Second Hospital of Jilin University
Changchun, China
Renji Hospital Affiliated to The Shanghai Jiao Tong University Medical School
Shanghai, China
Affiliated Hospital of Shanxi University of Traditional Chinese Medicine
Xianyang, China

โ€ฆand 9 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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