Safety Of Laparoscopic or Robotic Radical Hysterectomy Using Endoscopic sTapler for Inhibiting tumOr Spillage of Cervical Neoplasms (SOLUTION): a Phase II Study

Who is this study for? Adult female patients with Stage IB1 Cervical Squamous Cell Carcinoma, Adenocarcinoma, or Adenosquamous Carcinoma
What treatments are being studied? Robotic Radical Hysterectomy
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 20
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center, Sungkyunkwan University School of Medicine
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, Ajou University School of Medicine
RECRUITING
Suwon
Contact Information
Primary
Soo Jin Park, M.D.
soojin.mdpark@gmail.com
+82-02-2072-0897
Backup
Jaehee Mun, M.D.
jhee1315@gmail.com
+82-02-2072-2388
Time Frame
Start Date: 2020-07-02
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 124
Treatments
Experimental: SOLUTION group
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.
Related Therapeutic Areas
Sponsors
Leads: Seoul National University Hospital
Collaborators: Johnson & Johnson

This content was sourced from clinicaltrials.gov