Clinical trial · Interventional
Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)
NCT04929769CI-TRIAL-00054788LAUNCH 2recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IB1, IB2, IIA1).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Total Abdominal Radical Hysterectomy | Other | — | UNRESOLVED |
| Total Laparoscopic or Robotic Radical Hysterectomy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- the group of LRH
- interventionNames
- Other: Total Laparoscopic or Robotic Radical Hysterectomy
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- the group of ARH
- interventionNames
- Other: Total Abdominal Radical Hysterectomy
Primary outcomes (1)
- measure
- the rate of PFS at 5 years
- timeFrame
- 5 years from surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1). 2. Age ≥ 21 years and ≤ 70 years. 3. Surgery type B and C (refer to Q-M surgical staging) 4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin \> 60g/L Platelets \> 70\*109/L Leukocytes \> 3\*109/L Creatinine \< 50mg/dL Transaminase abnormal indicators ≤ 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. No history of other malignancies. 6. Non-pregnancy. 7. Physical strength classification: Karnofsky score ≥ 60; 8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclusion Criteria: 1. Those who are contraindicated for various surgeries and cannot undergo surgery. 2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. Patients with recurrent cervical cancer 4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.
References
Publications (1)
- DERIVEDWu X, Qiu L, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. Trials. 2022 Apr 8;23(1):269. doi: 10.1186/s13063-022-06245-5. PMID 35395868