Minimally invasive surgery for early stage cervical cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The SOLUTION trial investigates the safety and efficacy of performing radical hysterectomy using minimally invasive surgery with an endoscopic stapler in patients diagnosed with cervical cancer stage IB1. This approach aims to demonstrate that minimally invasive techniques are as safe as traditional open surgery. The study addresses concerns raised by previous trials regarding the potential risks associated with minimally invasive procedures, particularly the exposure of tumor cells to the peritoneal cavity. By employing specific surgical techniques, the trial seeks to minimize these risks and improve patient outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Where it's running

• Seoul National University Hospital
  Seoul, 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

Study contacts

• Principal investigator: Hee Seung Kim, M.D. Ph.D. — Seoul National University Hospital
• Study coordinator: Soo Jin Park, M.D.
• Email: soojin.mdpark@gmail.com
• Phone: +82-02-2072-0897

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.