NCT04370496

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
32mo left

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress69%
Jul 2020Dec 2028

First Submitted

Initial submission to the registry

April 19, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 1, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

July 2, 2020

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

June 26, 2023

Status Verified

June 1, 2023

Enrollment Period

8.5 years

First QC Date

April 19, 2020

Last Update Submit

June 23, 2023

Conditions

Cervical CancerCervical Cancer Stage IB1Minimally Invasive Surgery

Keywords

Cervical cancerCervical Cancer Stage IB1Minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • 4.5 year disease-free survival [DFS] rate

    Probability of no recurrence from the day of surgery until post-operative 4.5 years

    Examined at post-operative 4.5 years

Secondary Outcomes (3)

  • 4.5 year overall survival [OS] rate

    Examined at post-operative 4.5 years

  • Pattern of recurrence sites

    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

    Examined during operation and post-operative 4 and 6 weeks.

Study Arms (1)

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.

Procedure: Minimally invasive surgery using endoscopic stapler

Interventions

Minimally invasive surgery using endoscopic staplerPROCEDURE

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.

SOLUTION group

Eligibility Criteria

Age20 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligible patients must be diagnosed with cervical cancer, limiting eligibility to only females.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Samsung Medical Center, Sungkyunkwan University School of Medicine

Seoul, South Korea

RECRUITING

Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine

Suwon, South Korea

RECRUITING

Related Publications (9)

  • 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.

    PMID: 30638582BACKGROUND

  • Wood 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.

    PMID: 25901562BACKGROUND

  • Nam 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.

    PMID: 21841155RESULT

  • Park 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.

    PMID: 23737035RESULT

  • Ramirez 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.

    PMID: 30380365RESULT

  • Kohler 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.

    PMID: 31155516RESULT

  • Kim 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.

    PMID: 30642625RESULT

  • Park 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.

    PMID: 35346103DERIVED

  • Mun 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.

    PMID: 34481135DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Officials

  • Hee Seung Kim, M.D. Ph.D.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo Jin Park, M.D.

CONTACT

+82-02-2072-0897soojin.mdpark@gmail.com

Jaehee Mun, M.D.

CONTACT

+82-02-2072-2388jhee1315@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All 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.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 19, 2020

First Posted

May 1, 2020

Study Start

July 2, 2020

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

June 26, 2023

Record last verified: 2023-06

Locations

KR(3)