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Cervical Cancer Stage IB2SOLUTION2NCT07256977

Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer

A study testing Open radical hysterectomy and Minimally invasive radical hysterectomy in people with Cervical Cancer Stage IB2 and Cervical Cancer Stage IIa, run by Seoul National University Hospital at 1 site in South Korea.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer. Read more about this study

Who is it for?
Ages 20 years and older, women only
What is being tested?
Open radical hysterectomy and Minimally invasive radical hysterectomy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
494 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2026to 30 Jun 2035
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
  1. Inclusion Criteria:
  2. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
  3. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  4. Planned for Type B or C radical hysterectomy
  5. With adequate bone marrow, renal, and hepatic function
  • WBC >3.0 × 10⁹ cells/L
  • Platelets >100 × 10⁹ cells/L
  • Creatinine <180 μmol/L
  • Bilirubin <1.5 × normal range
  • AST, ALT < 3 × normal range
  1. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  2. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
  3. Signed and approved consent form

II. Exclusion Criteria:

  1. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
  2. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
  3. The following are observed on preoperative CT or MRI
  • Tumor size ≥4 cm
  • Lymph node metastasis (short axis ≥15 mm)
  • Paracervical invasion
  • Bladder or rectal invasion
  • Distant metastasis
  1. Prior pelvic or abdominal radiotherapy
  2. Prior neoadjuvant chemotherapy before surgery
  3. Unsuitable for surgery due to severe systemic disease at the investigator's discretion
  4. Difficult to consider intraoperative lymphatic mapping due to
  • Allergy to triphenylmethane compounds
  • History of prior retroperitoneal surgery
  • History of prior pelvic radiotherapy
  • Cases where cold knife or loop electrosurgical excision procedure (LEEP) was performed within 4 weeks prior to study participation
  • Allergy to triphenylmethane compounds

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hee Seung Kim, Professor contact

82-2-2072-4863

bboddi0311@snu.ac.kr

South Korea1 site

  • Seoul National University College of Medicine

    Seoul, 03080

    Hee Seung Kim, 82-2-2072-4863, bboddi0311@snu.ac.kr

Other trials in South Korea

About this study

Official title: A Multicenter Non-inferiority Randomized Controlled Trial on Minimally Invasive Radical Hysterectomy Using an Endoscopic Stapler to Prevent Tumor Spillage in Stage IB2-IIA1 Cervical Cancer

This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.

Read the detailed description

This study exclusively includes patients with stage IB2 or IIA1 cervical cancer who have tumors measuring 2 cm or larger but less than 4 cm. After randomization, one group undergoes radical hysterectomy via open surgery, while the other group undergoes minimally invasive radical hysterectomy using an endoscopic stapler. This approach using an endoscopic stapler aims to prevent intraoperative exposure of tumor cells to the abdominal cavity, comparable to open surgery, thereby enabling a comparison of therapeutic efficacy and safety.

Being tested
Open radical hysterectomy, Minimally invasive radical hysterectomy
Keywords
Cervical cancer, open radical hysterectomy, minimally invasive radical hysterectomy, endoscopic stapler, survival, complications, perioperative outcomes, postoperative pain, quality of life, recurrence pattern
Medical subject headings
Uterine Cervical Neoplasms, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Open radical hysterectomyDevice

    Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy

  • Minimally invasive radical hysterectomyDevice

    Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy

Study groups in NCT07256977
Study groupRoleWhat they receive
Open radical hysterectomyExperimentalRadical hysterectomy is performed via open surgery
Receives: Device: Open radical hysterectomy
Minimally invasive radical hysterectomyExperimentalRadical hysterectomy is performed via minimally invasive surgery
Receives: Device: Minimally invasive radical hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 4.5-year progression-free survival rate

    Proportion of patients alive without disease progression or death at 4.5 years after enrollment, as assessed by radiographic imaging and/or clinical criteria

    Measured: Up to 4.5 years after enrollment

Secondary outcomes (14)

  1. Intraoperative complcation rate

    Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events

    Measured: During surgery

  2. Postoperative acute complication rate within 4 weeks

    Proportion of patients experiencing acute postoperative complications within 4 weeks after surgery, including urinary tract infection, cardiopulmonary complications, thromboembolic events, bleeding or organ dysfunction

    Measured: Within 4 weeks after surgery

  3. Postoperative complication rate after 4 weeks

    Proportion of patients experiencing acute postoperative complications after 4 weeks after surgery, including lymphedema, incisional hernia and dehiscence

    Measured: Greater than 4 weeks up to 12 months post-surgery

  4. Operation time

    The total duration of a surgical procedure, specifically measured from the initial surgical incision to the final closure of the wound

    Measured: Peri-procedural

  5. Estimated blood loss

    The approximated volume of blood a patient is believed to have lost during a surgical procedure or an injury.

    Measured: Peri-procedural

  6. Transfusion requirement

    The need for administration of red blood cells to a patient to restore or maintain adequate oxygen-carrying capacity, hemostasis, and blood volume.

    Measured: From the surgical incision to the end of surgery (skin closure)

  7. Length of hospitalization

    The total duration (in days) between a patient's hospital admission and discharge.

    Measured: From date of hospital admission to date of hospital discharge, assessed up to 30 days.

  8. Postoperative pain

    Patient-reported pain intensity measured using a numeric rating scale (0-10)

    Measured: Assessed at each visit from Visit 2 (2 weeks) and Visit 17 (54 months). The score can range from 0 to 10, with a higher score indicating more severe pain.

  9. Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)

    Patient-reported quality of life evaluated using the FACT-Cx questionnaire, which includes physical, social/family, emotional, functional well-being, and cervix cancer-specific concerns. The FACT-Cx total score ranges from 0 to 168, with a higher score indicating better quality of life.

    Measured: Assessed at Visit 1(within 4 weeks), Visit 3(2 weeks), Visit 4(6 weeks), Visit 5(3 months), Visit 6(6 months), Visit 10(18 months), Visit 13(30 months), Visit 17(54 months).

  10. EQ-5D-5L

    Patient-reported health-related quality of life assessed using the EQ-5D questionnaire, including five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Scores will be converted to index values based on country-specific value sets, and EQ visual analog scale (EQ-VAS) will also be recorded. Higher scores indicate better health status.

    Measured: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score ranges from -0.594 to 1.000, showing that higher scores mean healthier.

  11. The 12-item Short Form Health Survey (SF-12)

    Patient-reported health-related quality of life assessed using the SF-12 questionnaire, which yields Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. Higher scores indicate better health status.

    Measured: Assessed at Visit 1 (within 4 weeks), Visit 3 (2 weeks), Visit 4 (6 weeks), Visit 5 (3 months), Visit 6 (6 months). The score can range from 0 to 100, with a higher score indicating less severe symptoms.

  12. Pelvic Floor Distress Inventory (PFDI)

    Patient-reported pelvic floor dysfunction symptoms assessed using the PFDI questionnaire, which includes subscales for urinary, colorectal-anal, and pelvic organ prolapse symptoms. Higher scores indicate greater symptom distress

    Measured: Assessed at Visit 1 (within 4 weeks), Visit 5 (3 months), Visit 6 (6 months), Visit 10 (18 months), Visit 13 (30 months), Visit 15 (42 months), Visit 17 (54 months). The score can range from 0 to 300, with a higher score indicating more severe symptoms.

  13. 4.5-year overall survival rate

    Overall survival defined as the time from date of surgery to death from any cause. The 4.5-year survival rate will be estimated using the Kaplan-Meier method. Patients alive at the end of follow-up will be censored at the last known contact.

    Measured: Up to 4.5 years after surgery

  14. Recurrence pattern at first recurrence

    Distribution of first recurrence sites categorized as central, pelvic sidewall, and distant metastases. Recurrence must be radiologically or pathologically confirmed.

    Measured: From date of surgery through 4.5 years postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2025
  2. Study start1 Jan 2026 (estimated)
  3. Primary completion31 Dec 2034 (estimated)
  4. Study completion30 Jun 2035 (estimated)

Resources

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
494 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256977
Sponsor's protocol ID
SOLUTION2
Other IDs
0620202330
Acronym
SOLUTION2
Status last verified
Nov 2025
First submitted
6 Oct 2025
Last updated
2 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Open radical hysterectomy and Minimally invasive radical hysterectomy in people with Cervical Cancer Stage IB2 and Cervical Cancer Stage IIa, run by Seoul National University Hospital at 1 site 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?

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: opening soon, as of the sponsor's last update on 2 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 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 Hee Seung Kim, Professor (82-2-2072-4863, bboddi0311@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

4.5-year progression-free survival rate (time frame: Up to 4.5 years after enrollment). 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 NCT07256977.

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 2 Dec 2025.

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