Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1) (LAUNCH 2)

Obstetrics & Gynecology Hospital of Fudan University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Other: Total Laparoscopic or Robotic Radical Hysterectomy; Other: Total Abdominal Radical Hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT04929769

FUOBGY2021-04

Details and patient eligibility

About

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).

Full description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), by a multicenter stratified randomized controlled study, mainly including the following aspects:

1. To compare the differences in PFS and OS between patients receiving LRH and ARH.
2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes).
3. To assess postoperative complications and quality of survival.

Enrollment: 780 estimated patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

780 participants in 2 patient groups

1

Experimental group

Description:

the group of LRH

Treatment:

Other: Total Laparoscopic or Robotic Radical Hysterectomy

2

Active Comparator group

Description:

the group of ARH

Treatment:

Other: Total Abdominal Radical Hysterectomy