Uterine Cervical Neoplasm Clinical Trial
— RWS-01Official title:
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer, A Multicenter, Prospective and Non-Randomized Controlled Trial
Cervical cancer is the most common cause of death from gynecological cancer world-wide. With
technological innovation, minimally invasive or even non-invasive medical treatment has
become a trend. Since the first cases of laparoscopic radical hysterectomy of cervical cancer
have been reported in 1992, many single-center observational cohort studies have shown that
compared to open abdominal surgery ,minimally invasive surgery (laparoscopic or robotic
radical hysterectomy) showed advantages of less blood loss, shorter hospital stay and fewer
intraoperative complications, while the 5-year survival and disease-free survival were
similar. The NCCN guidelines and ESGO recommendations also clearly indicated that patients
with FIGO stage IA2 -IIA cervical cancer could undergo open or laparoscopic/robotic radical
hysterectomy. However, in October 2018, the results of two studies published in the《New
England Journal of Medicine》have subverted our traditional perception of minimally invasive
surgery and caused widespread controversy in the field of gynecologic oncology treatment.
Both studies showed that the survival rate in the minimally invasive surgery group was lower
than that in the open surgery group.
The results of these two studies have brought unprecedented doubts and challenges to the
minimally invasive surgery for cervical cancer. The MD Anderson Cancer Center has even
stopped minimally invasive surgery for cervical cancer. Several hospitals in Hong Kong have
responded similarly. The NCCN guidelines are also quickly updated based on the results of
those studies: patients should be informed of the results of this study and doctors should
respect the patient's choices. The above research results have also attracted the attention
of many gynecological oncologists in the mainland China. Some experts questioned the design
of this study design as well as surgical skills. We need to look at these findings
cautiously. So, we launched a real-world study of clinical outcomes affected by different
surgical treatment for patients of early stage cervical cancer. We plan to recruit 2000
patients with early cervical cancer from 20-30 selected surgical centers nationwide and
perform surgery on patients with qualified and experienced doctors.We will inform the
patients current status of the study in detail, divide the patients into different
observational group according to their choices on surgical methods. The patients will be
followed up closely after surgery. We will compare the differences in clinical outcomes
between the two surgical methods and conduct subgroup and stratified analysis. We hope that
this study can truly reflect the actual status and clinical l level of early cervical cancer
treatment in China, and provide a high level of clinical evidence for the treatment of
cervical cancer in China .
Status | Recruiting |
Enrollment | 2000 |
Est. completion date | May 2024 |
Est. primary completion date | May 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with FIGO stage (2018) IA1 (with lymph vascular space invasion), IA2, IB1, IB2 or IIA1 disease - Preoperative histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix - Age = 65 years old; - Physical grading: Karnofsky score = 60 points; - Initial treatment; - Voluntarily joined the study, signed informed consent, willing to comply, and cooperative with follow-up; (Note: The maximum diameter of the cervical lesion is subject to MRI measurements) Exclusion Criteria for Preoperative Patients: - Patients with contraindications to surgery; - Patients who have previously received pelvic/abdominal radiation or chemotherapy;Patients who had received radiotherapy and chemotherapy for other cancers in the past. - Patients with evidence of extra cervical metastases by CT, MRI or PET. - Unable or unwilling to sign informed consent. - Unable or unwilling to comply with research requirements. - Patients with diameter of lymph node metastasis = 2 cm by preoperative MRI. - Patients with pregnancy. - Patients requiring fertility-preserving surgery. - Patients who had previously received subtotal hysterectomy. - Patients participating in other clinical trials. - Patients with other reasons not suitable clinical trials identified by researchers. Exclusion Criteria for Postoperative Patients: - Postoperative pathology: endometrioid adenocarcinoma, clear cell carcinoma, special type adenocarcinoma, neuroendocrine carcinoma (small cell carcinoma), tuberculosis. - Postoperative tumor size = 4 cm. - Patients with abdominal aortic lymph node metastasis. - Patients with severe postoperative complications that are not suitable for adjuvant therapy and affect patient follow-up. - Patients who did not follow requirements for various reasons (except for various complications and deaths caused by tumor recurrence and metastasis). - Situation which researchers believe that treatment should be terminated. |
Country | Name | City | State |
---|---|---|---|
China | Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Wuhan | Hubei |
Lead Sponsor | Collaborator |
---|---|
Ding Ma |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | disease-free survival (DFS) of 3 years and 5 years | DFS was definite as the time from surgery to disease recurrence | up to 5 years | |
Secondary | overall survival (OS) of 3 years and 5 years | OS was defined as time from surgery to death by any cause | up to 5 years |
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