RecruitingNot Applicable

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)

China690 participantsStarted 2021-09-24

Plain-language summary

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 IA1 with LVSI, IA2)

Who can participate

Age range21 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2).
✓. Age ≥ 21 years and ≤ 70 years.
✓. Surgery type B and C (refer to Q-M surgical staging)
✓. 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.
✓. No history of other malignancies.
✓. Non-pregnancy.
✓. Physical strength classification: Karnofsky score ≥ 60;
✓. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.

Exclusion criteria

✕. Those who are contraindicated for various surgeries and cannot undergo surgery.
✕. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
✕. Patients with recurrent cervical cancer
✕. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter \>2cm after further improvement of preoperative examination.

What they're measuring

the rate of PFS at 5 years

Timeframe: 5 years from surgery

Trial details

NCT IDNCT04934982

SponsorHua Jiang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Contact for this trial

Hua Jiang, PHD

(021)33189900-6529 jianghua@fudan.edu.cn

View on ClinicalTrials.gov More Cervical Cancer trials