Uterine Cervical NeoplasmCGOG 002NCT03955185
Clinical Trial of Minimally Invasive Surgery Versus Abdominal Surgery in Patients With Early Stage Cervical Cancer
A study testing minimally invasive surgery and open abdominal surgery in people with Uterine Cervical Neoplasm, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Uterine Cervical Neoplasm
- What is being tested?
- minimally invasive surgery and open abdominal surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 1 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430030
About this study
Official title: A Non-randomized Controlled Study of Minimally Invasive Versus Abdominal Radical Hysterectomy for Cervical Cancer
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 .
Read the detailed description
The study is a non-randomized, prospective, multi-center, clinical study.Patients with early cervical cancer who were enrolled will be divided into two groups: minimally invasive surgery group (group A) and open abdominal surgery group (group B) according to the patient's choice on surgical methods.We will standardize the surgery details according to the factors that may affect the prognosis of cancer treatment in the minimally invasive surgery of cervical cancer, such as : emphasizing the tumor-free principle of surgery; using a ligation band to tighten the vagina before cutting the vagina; avoiding the use of the cup-shaped uterine manipulator；reducing frequent changes in CO2 abdominal pressure；or using a laparoscope-assist transvaginal hysterectomy and other methods to avoid the risk of tumor tissue shedding. Patients with high risk factors after surgery will receive follow-up treatment according to the 2018 NCCN guidelines.
- Conditions
- Uterine Cervical Neoplasm
- Being tested
- minimally invasive surgery, open abdominal surgery
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive surgeryProcedure or surgery
Laparoscopic or robotic assisted radical hysterectomy
open abdominal surgeryProcedure or surgery
Traditional open abdominal radical hysterectomy
| Study group | Role | What they receive |
|---|---|---|
| Minimally invasive surgery | Experimental | The patients will receive laparoscopic or robotic assisted radical hysterectomy with improved surgery details: 1) Uterine manipulator type Cup-shaped uterine manipulator is prohibited, uterus hanging wire is allowed. 2) Avoid tumor cells shedding into the pelvis: A. Cut the vagina with the transvaginal method, B. Cut the vagina after closed loop ligation of the vagina. After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines. Receives: Procedure: minimally invasive surgery |
| Open abdominal surgery | Active comparator | The patients will receive traditional radical hysterectomy.After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines. Receives: Procedure: open abdominal surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
disease-free survival (DFS) of 3 years
DFS was definite as the time from surgery to disease recurrence
Measured: 3 years
overall survival (OS) of 5 years
OS was defined as time from surgery to death by any cause
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 May 2019
- Primary completion1 May 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine Cervical NeoplasmStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ma, Huazhong University of Science and Technology
- Investigators
- Ding Ma, MD;PHD, Study chair, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955185
- Sponsor's protocol ID
- CC-Surgery1
- Acronym
- CGOG 002
- Status last verified
- Oct 2025
- First submitted
- 16 May 2019
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized Controlled Study of Minimally Invasive Versus Abdominal Radical Hysterectomy for Cervical Cancer
- ClinicalTrials.gov ID
- NCT03955185
- Acronym / sponsor ID
- CGOG 002 / CC-Surgery1
- Conditions
- Uterine Cervical Neoplasm
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 20 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
The study is a non-randomized, prospective, multi-center, clinical study.Patients with early cervical cancer who were enrolled will be divided into two groups: minimally invasive surgery group (group A) and open abdominal surgery group (group B) according to the patient's choice on surgical methods.We will standardize the surgery details according to the factors that may affect the prognosis of cancer treatment in the minimally invasive surgery of cervical cancer, such as : emphasizing the tumor-free principle of surgery; using a ligation band to tighten the vagina before cutting the vagina; avoiding the use of the cup-shaped uterine manipulator；reducing frequent changes in CO2 abdominal pressure；or using a laparoscope-assist transvaginal hysterectomy and other methods to avoid the risk of tumor tissue shedding. Patients with high risk factors after surgery will receive follow-up treatment according to the 2018 NCCN guidelines.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minimally invasive surgery | Experimental | Procedure: minimally invasive surgeryThe patients will receive laparoscopic or robotic assisted radical hysterectomy with improved surgery details: 1) Uterine manipulator type Cup-shaped uterine manipulator is prohibited, uterus hanging wire is allowed. 2) Avoid tumor cells shedding into the pelvis: A. Cut the vagina with the transvaginal method, B. Cut the vagina after closed loop ligation of the vagina. After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines. |
| Open abdominal surgery | Active comparator | Procedure: open abdominal surgeryThe patients will receive traditional radical hysterectomy.After the surgery, they will receive adjuvant therapy according to the pathological risk factors refer to the 2018 NCCN guidelines. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive surgeryLaparoscopic or robotic assisted radical hysterectomy | Procedure or surgery | Minimally invasive surgery |
| open abdominal surgeryTraditional open abdominal radical hysterectomy | Procedure or surgery | Open abdominal surgery |
Primary outcome
disease-free survival (DFS) of 3 years
Time frame: 3 years
DFS was definite as the time from surgery to disease recurrence
overall survival (OS) of 5 years
Time frame: up to 5 years
OS was defined as time from surgery to death by any cause
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: Undecided. The individual participants data will be preserved in the hospital, and all the chemical or physical examination results will be kept in the medical records, the researches, ethics committee and the drug administration will be permitted to look up all the records as we planned. And all the reports or papers about this research will not relate to the patients' identity. But we do not decide whether the information be available to others, the final decision maybe decided by all the patients in this research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ding Ma, MD;PHD study chair
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive surgery and open abdominal surgery in people with Uterine Cervical Neoplasm, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disease-free survival (DFS) of 3 years (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.