Cervical CancerSOLUTIONNCT04370496
Safety of Minimally Invasive Surgery Using Endoscopic Stapler in Early Stage Cervical Cancer Patients (SOLUTION)
A study testing Minimally invasive surgery using endoscopic stapler in people with Cervical Cancer and Cervical Cancer Stage IB1, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery. Read more about this study
- Who is it for?
- Ages 20 years and older, women only
- Conditions the study is for
- Cervical Cancer, Cervical Cancer Stage IB1, Minimally Invasive Surgery
- What is being tested?
- Minimally invasive surgery using endoscopic stapler
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 2 Jul 2020to 31 Dec 2028
- 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 20 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females, aged 20 years or older
- Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- Patients with FIGO stage IB1 (FIGO staging 2009)
- : stromal invasion>5 mm or 7 mm <lesion size ≤4 cm
- Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)
- Patients with normal bone marrow, renal and hepatic function
Show all 13Show fewer
- WBC > 3.0x10^9 cells/L
- Platelets > 100x10^9 cells/L
- Serum creatinine ≤1.5 mg/dL
- Serum total bilirubin <1.5 x normal range and AST/SGOT or ALT/SGPT <3 x normal range
- ECOG performance status 0 or 1
- Synchronous cancer with no evidence of recurrence during the past 5 years
- Informed consent of patient
Who cannot join
- Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)
- stromal invasion ≤5 mm and lesion size ≤7 mm (less than IA2)
- or lesion size> 4 cm (greater than IB2)
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes
Show all 14Show fewer
- Patients in pregnancy
- Patients with a history of pelvic or abdominal radiotherapy
- Patients with contraindication of surgery (serious concomitant systemic disorders incompatible with the study to be decided at the discretion of the investigator)
- Patients who agree to intra-operative lymphatic mapping (IOLM) must not have:
- Known allergies to triphenylmethane compounds
- History of retroperitoneal surgery.
- History of pelvic irradiation.
- Cold knife or LEEP cone biopsy within 4 weeks of enrollment
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Soo jin Park, MD, 82-2-2072-0897, soojin.mdpark@gmail.com
Maria Lee, MD
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul
Yoo Young Lee, MD
Chel Hun Choi, MD
- Recruiting
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
Suwon
Tae Wook Kong, MD
Suk Joon Chang, MD
About this study
Official title: Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
The SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
Read the detailed description
Cervical cancer is the 4th most common gynecologic cancer and treatment in early stages consists of surgery, chemotherapy, or radiation therapy. Surgical methods are simple or radical hysterectomy and pelvic and para-aortic lymph node dissection either done in an open manner or minimally invasive surgery (robotic or laparoscopic). However, a phase III cinical trial in 2018 comparing the safety and efficacy between minimally invasive surgery and open surgery in performing radical hysterectomy, 'Laparoscopic Approach to Cervical Cancer' (LACC), showed that open surgery is safer than minimally invasive surgery. Possible causes of such results are as follows:
- Carbon dioxide is supplied during laparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation of tumor cells exposed to the peritoneal cavity.
- Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges.
- Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy.
- Tumor cells exposed to the peritoneal cavity can travel upwards when the patient's position is maintained in the Trendelenburg position during minimally invasive operations, leading to distant metastasis.
Based on the above-mentioned hypothesis, the following methods could be applied to minimize the exposure of tumor cells to the peritoneal cavity.
- The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges.
- The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells.
- The performance of extracorporeal colpotomy instead to prevent the exposure of tumor cells inside the peritoneal cavity.
Although it would be favorable to perform all the forementioned methods, extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method is to use an endoscopic stapler which can simultaneously cut and suture the cervix into a vaginal stump, which can prevent tumor cells from being exposed to the peritoneal cavity.
In conclusion, this clinical trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
- Being tested
- Minimally invasive surgery using endoscopic stapler
- Keywords
- Cervical cancer, Cervical Cancer Stage IB1, Minimally invasive 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 surgery using endoscopic staplerProcedure or surgery
Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.
| Study group | Role | What they receive |
|---|---|---|
| SOLUTION group | Experimental | Patients enrolled in this clinical trial will undergo radical hysterectomy through minimally invasive surgery using an endoscopic stapler which both cuts and simultaneously sutures the open vaginal stump. Receives: Procedure: Minimally invasive surgery using endoscopic stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
4.5 year disease-free survival [DFS] rate
Probability of no recurrence from the day of surgery until post-operative 4.5 years
Measured: Examined at post-operative 4.5 years
Secondary outcomes (3)
4.5 year overall survival [OS] rate
Rate of survival from the day of surgery until post-operative 4.5 years
Measured: Examined at post-operative 4.5 years
Pattern of recurrence sites
Anatomical site of recurrent cancer according to imaging modalities
Measured: Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years
Morbidity
Intra-operative and post-operative complications occurring in less than post-operative 4 weeks and between post-operative 4 and 6 weeks. Other morbidity include estimated blood loss during surgery, post-operative pain and amount of analgesic consumption
Measured: Examined during operation and post-operative 4 and 6 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start2 Jul 2020
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Patients enrolled in this clinical trial will undergo surgery for early stage cervical cancer. They will receive either laparoscopic or robotic radical hysterectomy using an endoscopic stapler. The efficacy and safety of this surgical technique will be compared to that of open radical hysterectomy studied in previous trials.
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Hee Seung Kim, Seoul National University Hospital
- Investigators
- Hee Seung Kim, M.D. Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370496
- Sponsor's protocol ID
- IRB No. 2002-101-1103
- Acronym
- SOLUTION
- Status last verified
- Jun 2023
- First submitted
- 19 Apr 2020
- Last updated
- 26 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan whether to share IPD will be decided once enrollment of the clinical trial starts.
Publications
Cohen PA, Jhingran A, Oaknin A, Denny L. Cervical cancer. Lancet. 2019 Jan 12;393(10167):169-182. doi: 10.1016/S0140-6736(18)32470-X.
PubMed 30638582Wood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015 May;25(2):185-97. doi: 10.1016/j.thorsurg.2014.12.003. Epub 2015 Jan 28.
PubMed 25901562Nam JH, Park JY, Kim DY, Kim JH, Kim YM, Kim YT. Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: long-term survival outcomes in a matched cohort study. Ann Oncol. 2012 Apr;23(4):903-11. doi: 10.1093/annonc/mdr360. Epub 2011 Aug 12.
PubMed 21841155Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. Laparoscopic versus open radical hysterectomy in patients with stage IB2 and IIA2 cervical cancer. J Surg Oncol. 2013 Jul;108(1):63-9. doi: 10.1002/jso.23347. Epub 2013 Jun 5.
PubMed 23737035Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
PubMed 30380365Kohler C, Hertel H, Herrmann J, Marnitz S, Mallmann P, Favero G, Plaikner A, Martus P, Gajda M, Schneider A. Laparoscopic radical hysterectomy with transvaginal closure of vaginal cuff - a multicenter analysis. Int J Gynecol Cancer. 2019 Jun;29(5):845-850. doi: 10.1136/ijgc-2019-000388.
PubMed 31155516Kim SI, Cho JH, Seol A, Kim YI, Lee M, Kim HS, Chung HH, Kim JW, Park NH, Song YS. Comparison of survival outcomes between minimally invasive surgery and conventional open surgery for radical hysterectomy as primary treatment in patients with stage IB1-IIA2 cervical cancer. Gynecol Oncol. 2019 Apr;153(1):3-12. doi: 10.1016/j.ygyno.2019.01.008. Epub 2019 Jan 12.
PubMed 30642625Park SJ, Kong TW, Kim T, Lee M, Choi CH, Shim SH, Yim GW, Lee S, Lee EJ, Lim MC, Chang SJ, Lee SJ, Lee SH, Song T, Lee YY, Kim HS, Nam EJ. Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol. BMC Cancer. 2022 Mar 26;22(1):331. doi: 10.1186/s12885-022-09429-z.
PubMed 35346103Mun J, Park SJ, Yim GW, Chang SJ, Kim H; Trial Monitoring Committee of SOLUTION trial. Solution to prevent tumor spillage in minimally invasive radical hysterectomy using the endoscopic stapler for treating early-stage cervical cancer: Surgical technique with video. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102211. doi: 10.1016/j.jogoh.2021.102211. Epub 2021 Sep 1.
PubMed 34481135
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study
- ClinicalTrials.gov ID
- NCT04370496
- Acronym / sponsor ID
- SOLUTION / IRB No. 2002-101-1103
- Keywords
- Cervical cancer, Cervical Cancer Stage IB1, Minimally invasive surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 May 2020 (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 SOLUTION trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
Detailed description
Cervical cancer is the 4th most common gynecologic cancer and treatment in early stages consists of surgery, chemotherapy, or radiation therapy. Surgical methods are simple or radical hysterectomy and pelvic and para-aortic lymph node dissection either done in an open manner or minimally invasive surgery (robotic or laparoscopic). However, a phase III cinical trial in 2018 comparing the safety and efficacy between minimally invasive surgery and open surgery in performing radical hysterectomy, 'Laparoscopic Approach to Cervical Cancer' (LACC), showed that open surgery is safer than minimally invasive surgery. Possible causes of such results are as follows:
- Carbon dioxide is supplied during laparoscopic operations to maintain capnoperitoneum, which can cause the implantation and proliferation of tumor cells exposed to the peritoneal cavity.
- Insertions of uterine manipulators into the endometrial cavity is commonly done, which can cause tumor cells to travel to both salpinges.
- Tumor cells can be exposed to the peritoneal cavity when the cervix is exposed during intracorporeal colpotomy.
- Tumor cells exposed to the peritoneal cavity can travel upwards when the patient's position is maintained in the Trendelenburg position during minimally invasive operations, leading to distant metastasis.
Based on the above-mentioned hypothesis, the following methods could be applied to minimize the exposure of tumor cells to the peritoneal cavity.
- The application of a vaginal tube instead of a uterine manipulator to prevent tumor cells from traveling to the salpinges.
- The ligation of both salpinges prior to insertion of a vaginal tube to block the travel of tumor cells.
- The performance of extracorporeal colpotomy instead to prevent the exposure of tumor cells inside the peritoneal cavity.
Although it would be favorable to perform all the forementioned methods, extracorporeal colpotomy is difficult to perform especially in menopausal patients with atrophic vaginitis or patients with no sexual experience. Thus, an alternative method is to use an endoscopic stapler which can simultaneously cut and suture the cervix into a vaginal stump, which can prevent tumor cells from being exposed to the peritoneal cavity.
In conclusion, this clinical trial aims to show the efficacy and safety of performing radical hysterectomy by minimally invasive surgery using an endoscopic stapler in patients with cervical cancer stage IB1 (FIGO staging 2009) and thus to prove that minimally invasive surgery is non-inferior to open surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients enrolled in this clinical trial will undergo surgery for early stage cervical cancer. They will receive either laparoscopic or robotic radical hysterectomy using an endoscopic stapler. The efficacy and safety of this surgical technique will be compared to that of open radical hysterectomy studied in previous trials.
| Arm | Type | Receives |
|---|---|---|
| SOLUTION group | Experimental | Procedure: Minimally invasive surgery using endoscopic staplerPatients enrolled in this clinical trial will undergo radical hysterectomy through minimally invasive surgery using an endoscopic stapler which both cuts and simultaneously sutures the open vaginal stump. |
Who may qualify
- Ages
- 20 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Females, aged 20 years or older
- Histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- Patients with FIGO stage IB1 (FIGO staging 2009)
- : stromal invasion>5 mm or 7 mm <lesion size ≤4 cm
- Patients undergoing either type B or C hysterectomy (Querleu-Morrow classification)
Key exclusion criteria (14 listed)
- Any histological type other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
- Tumor size greater than 4 cm
- Patients with FIGO less than stage IA2 or greater than IB2 (FIGO staging 2009)
- Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes greater than 2 cm, or histologically positive lymph nodes
- Patients in pregnancy
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 surgery using endoscopic staplerRadical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix. | Procedure or surgery | SOLUTION group |
Primary outcome
4.5 year disease-free survival [DFS] rate
Time frame: Examined at post-operative 4.5 years
Probability of no recurrence from the day of surgery until post-operative 4.5 years
3 secondary outcomes
4.5 year overall survival [OS] rate
Time frame: Examined at post-operative 4.5 years
Pattern of recurrence sites
Time frame: Examined every 3 months during post-operative 1 year, every 2 months during post-operative 2 years, and every 6 months during post-operative 4.5 years
Morbidity
Time frame: Examined during operation and post-operative 4 and 6 weeks.
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 26 Jun 2023.
- Background: PubMed 30638582Cohen PA, Jhingran A, Oaknin A, Denny L. Cervical cancer. Lancet. 2019 Jan 12;393(10167):169-182. doi: 10.1016/S0140-6736(18)32470-X.
- Background: PubMed 25901562Wood DE. National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Lung Cancer Screening. Thorac Surg Clin. 2015 May;25(2):185-97. doi: 10.1016/j.thorsurg.2014.12.003. Epub 2015 Jan 28.
- Results publication: PubMed 21841155Nam JH, Park JY, Kim DY, Kim JH, Kim YM, Kim YT. Laparoscopic versus open radical hysterectomy in early-stage cervical cancer: long-term survival outcomes in a matched cohort study. Ann Oncol. 2012 Apr;23(4):903-11. doi: 10.1093/annonc/mdr360. Epub 2011 Aug 12.
- Results publication: PubMed 23737035Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. Laparoscopic versus open radical hysterectomy in patients with stage IB2 and IIA2 cervical cancer. J Surg Oncol. 2013 Jul;108(1):63-9. doi: 10.1002/jso.23347. Epub 2013 Jun 5.
- Results publication: PubMed 30380365Ramirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31.
- Results publication: PubMed 31155516Kohler C, Hertel H, Herrmann J, Marnitz S, Mallmann P, Favero G, Plaikner A, Martus P, Gajda M, Schneider A. Laparoscopic radical hysterectomy with transvaginal closure of vaginal cuff - a multicenter analysis. Int J Gynecol Cancer. 2019 Jun;29(5):845-850. doi: 10.1136/ijgc-2019-000388.
- Results publication: PubMed 30642625Kim SI, Cho JH, Seol A, Kim YI, Lee M, Kim HS, Chung HH, Kim JW, Park NH, Song YS. Comparison of survival outcomes between minimally invasive surgery and conventional open surgery for radical hysterectomy as primary treatment in patients with stage IB1-IIA2 cervical cancer. Gynecol Oncol. 2019 Apr;153(1):3-12. doi: 10.1016/j.ygyno.2019.01.008. Epub 2019 Jan 12.
- Derived from this study: PubMed 35346103Park SJ, Kong TW, Kim T, Lee M, Choi CH, Shim SH, Yim GW, Lee S, Lee EJ, Lim MC, Chang SJ, Lee SJ, Lee SH, Song T, Lee YY, Kim HS, Nam EJ. Safety and efficacy study of laparoscopic or robotic radical surgery using an endoscopic stapler for inhibiting tumour spillage of cervical malignant neoplasms evaluating survival (SOLUTION): a multi-centre, open-label, single-arm, phase II trial protocol. BMC Cancer. 2022 Mar 26;22(1):331. doi: 10.1186/s12885-022-09429-z.
- Derived from this study: PubMed 34481135Mun J, Park SJ, Yim GW, Chang SJ, Kim H; Trial Monitoring Committee of SOLUTION trial. Solution to prevent tumor spillage in minimally invasive radical hysterectomy using the endoscopic stapler for treating early-stage cervical cancer: Surgical technique with video. J Gynecol Obstet Hum Reprod. 2021 Dec;50(10):102211. doi: 10.1016/j.jogoh.2021.102211. Epub 2021 Sep 1.
- Individual participant dataSharing planned: Undecided. The plan whether to share IPD will be decided once enrollment of the clinical trial starts.
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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.
Hee Seung Kim, M.D. Ph.D. principal investigator
Seoul National University Hospital
3 sites 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 using endoscopic stapler in people with Cervical Cancer and Cervical Cancer Stage IB1, run by Seoul National University Hospital at 3 sites in South Korea.
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 13 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 26 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. 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?
Contact Soo Jin Park, M.D. (+82-02-2072-0897, soojin.mdpark@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
4.5 year disease-free survival [DFS] rate (time frame: Examined at post-operative 4.5 years). 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 NCT04370496, which also lists 9 linked publications.
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 26 Jun 2023.