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| ID | Type | Description | Link |
|---|---|---|---|
| 0620202330 | Other Grant/Funding Number | Johnson @ Johnson |
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| Name | Class |
|---|---|
| Ajou University School of Medicine | OTHER |
| SMG-SNU Boramae Medical Center | OTHER |
| Konkuk University | OTHER |
| DongGuk University |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open radical hysterectomy | Experimental | Radical hysterectomy is performed via open surgery |
|
| Minimally invasive radical hysterectomy | Experimental | Radical hysterectomy is performed via minimally invasive surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open radical hysterectomy | Device | Radical hysterectomy is performed via open surgery, and Wertheim clamp is used for preventing tumor spillage during colpotomy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 4.5 years after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative complcation rate | Proportion of patients experiencing intraoperative complications, including anesthesia-related adverse events, bleeding, organ injury, or other unexpected intraoperative events | During surgery |
| Postoperative acute complication rate within 4 weeks |
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I. Inclusion Criteria:
2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and <4 cm)
Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Planned for Type B or C radical hysterectomy
With adequate bone marrow, renal, and hepatic function
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
Signed and approved consent form
II. Exclusion Criteria:
Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
The following are observed on preoperative CT or MRI
Prior pelvic or abdominal radiotherapy
Prior neoadjuvant chemotherapy before surgery
Unsuitable for surgery due to severe systemic disease at the investigator's discretion
Difficult to consider intraoperative lymphatic mapping due to
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hee Seung Kim, Professor | Contact | 82-2-2072-4863 | bboddi0311@snu.ac.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University College of Medicine | Seoul | 03080 | South Korea |
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| OTHER |
| Keimyung University | OTHER |
| National Cancer Center, Korea | OTHER_GOV |
| The Catholic University of Korea | OTHER |
| Wonju Severance Christian Hospital | OTHER |
| Kangbuk Samsung Hospital | OTHER |
| Asan Medical Center | OTHER |
| Samsung Medical Center | OTHER |
| Sinchon Severance Hospital, Yonsei University College of Medicine | UNKNOWN |
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| Minimally invasive radical hysterectomy | Device | Radical hysterectomy is performed via minimally invasive surgery, and an endoscopic stapler is used for preventing tumor spillage during colpotomy |
|
Proportion of patients experiencing acute postoperative complications within 4 weeks after surgery, including urinary tract infection, cardiopulmonary complications, thromboembolic events, bleeding or organ dysfunction |
| Within 4 weeks after surgery |
| Postoperative complication rate after 4 weeks | Proportion of patients experiencing acute postoperative complications after 4 weeks after surgery, including lymphedema, incisional hernia and dehiscence | Greater than 4 weeks up to 12 months post-surgery |
| Operation time | The total duration of a surgical procedure, specifically measured from the initial surgical incision to the final closure of the wound | Peri-procedural |
| Estimated blood loss | The approximated volume of blood a patient is believed to have lost during a surgical procedure or an injury. | Peri-procedural |
| 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. | From the surgical incision to the end of surgery (skin closure) |
| Length of hospitalization | The total duration (in days) between a patient's hospital admission and discharge. | From date of hospital admission to date of hospital discharge, assessed up to 30 days. |
| Postoperative pain | Patient-reported pain intensity measured using a numeric rating scale (0-10) | 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. |
| 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. | 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). |
| 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. | 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. |
| 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. | 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. |
| 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 | 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. |
| 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. | Up to 4.5 years after surgery |
| 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. | From date of surgery through 4.5 years postoperatively |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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