Cervical CancerLAUNCH 3NCT04939831
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
A study testing Total Laparoscopic or Robotic Radical Hysterectomy and Total Abdominal Radical Hysterectomy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University at 1 site in China.
Trial summary
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2). Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Total Laparoscopic or Robotic Radical Hysterectomy and Total Abdominal Radical Hysterectomy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,104 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2021to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
- Age ≥ 21 years and ≤ 70 years.
- Surgery type B and C (refer to Q-M surgical staging)
- Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
- No history of other malignancies.
- Non-pregnancy.
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- Physical strength classification: Karnofsky score ≥ 60;
- Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.
- No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI)
Who cannot join
- Those who are contraindicated for various surgeries and cannot undergo surgery.
- Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
- Patients with recurrent cervical cancer
- Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Obstetrics and Gynecology Hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Hua Jiang, PHD, (86)13601978182, jianghua@fudan.edu.cn
About this study
Official title: A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).
Read the detailed description
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:
- To compare the differences in PFS and OS between patients receiving LRH and ARH.
- To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
- To assess postoperative complications and quality of survival.
- Conditions
- Cervical Cancer
- Being tested
- Total Laparoscopic or Robotic Radical Hysterectomy, Total Abdominal Radical Hysterectomy
- Keywords
- Cervical Cancer, Abdominal Radical Hysterectomy, Laparoscopic Radical Hysterectomy
- 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.
Total Laparoscopic or Robotic Radical HysterectomyOther
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
Total Abdominal Radical HysterectomyOther
Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | the group of LRH Receives: Other: Total Laparoscopic or Robotic Radical Hysterectomy |
| 2 | Active comparator | the group of ARH Receives: Other: Total Abdominal Radical Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of OS at 5 years
Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)
Measured: 5 years from surgery
Secondary outcomes (1)
the rate of PFS at 5 years
The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated.
Measured: 5 years from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start12 May 2021
- Primary completionJun 2024 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, RenJi Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, First Affiliated Hospital of Wenzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Hua Jiang, PHD, Principal investigator, The Obstetrics and Gynecology Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939831
- Sponsor's protocol ID
- FUOBGY2021-05
- Acronym
- LAUNCH 3
- Status last verified
- Nov 2021
- First submitted
- 9 Jun 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wu X, Yu H, Bai Y, Hou Y, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Yan W, Qiu L, Feng H, Zhu S, Du Y, Jiang H. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial. Trials. 2023 Aug 18;24(1):542. doi: 10.1186/s13063-023-07573-w.
PubMed 37592299
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)
- ClinicalTrials.gov ID
- NCT04939831
- Acronym / sponsor ID
- LAUNCH 3 / FUOBGY2021-05
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Abdominal Radical Hysterectomy, Laparoscopic Radical Hysterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,104 participants (estimated)
- Lead sponsor
- Obstetrics & Gynecology Hospital of Fudan UniversityUniversity, hospital or other
- Collaborators
- Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, RenJi Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, First Affiliated Hospital of Wenzhou Medical University
- Study start
- 12 May 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 25 Jun 2021 (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.
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB3, IIA2).
Detailed description
The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB3, IIA2), by a multicenter stratified randomized controlled study, mainly including the following aspects:
- To compare the differences in PFS and OS between patients receiving LRH and ARH.
- To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
- To assess postoperative complications and quality of survival.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Total Laparoscopic or Robotic Radical Hysterectomythe group of LRH |
| 2 | Active comparator | Other: Total Abdominal Radical Hysterectomythe group of ARH |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
- Age ≥ 21 years and ≤ 70 years.
- Surgery type B and C (refer to Q-M surgical staging)
- Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value.
- No history of other malignancies.
Key exclusion criteria (4 listed)
- Those who are contraindicated for various surgeries and cannot undergo surgery.
- Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
- Patients with recurrent cervical cancer
- Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.
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 |
|---|---|---|
| Total Laparoscopic or Robotic Radical HysterectomyRadical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina. | Other | 1 |
| Total Abdominal Radical HysterectomyRadical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina. | Other | 2 |
Primary outcome
the rate of OS at 5 years
Time frame: 5 years from surgery
Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.)
1 secondary outcome
the rate of PFS at 5 years
Time frame: 5 years from surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Derived from this study: PubMed 37592299Wu X, Yu H, Bai Y, Hou Y, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Yan W, Qiu L, Feng H, Zhu S, Du Y, Jiang H. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial. Trials. 2023 Aug 18;24(1):542. doi: 10.1186/s13063-023-07573-w.
- Individual participant dataSharing planned: No
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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.
Hua Jiang, PHD principal investigator
The Obstetrics and Gynecology Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Laparoscopic or Robotic Radical Hysterectomy and Total Abdominal Radical Hysterectomy in people with Cervical Cancer, run by Obstetrics & Gynecology Hospital of Fudan University 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 9 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hua Jiang, PHD ((021)33189900-6529, jianghua@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the rate of OS at 5 years (time frame: 5 years from surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04939831, which also lists 1 linked publication.
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 10 Nov 2021.