Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer

Last updated: August 29, 2023
Sponsor: Chongqing University Cancer Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cervical Cancer

Uterine Disorders

Treatment

Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation

Concurrent chemoradiation

Clinical Study ID

NCT05378087
CQGOG0106
  • Ages 18-75
  • Female

Study Summary

The study is a domestic multicenter, prospective, non-randomized controlled concurrent trial. It will be assessed whether surgery staging on locally advanced cervical cancer is superior to image staging for improving progression-free survival and overall survival.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. The patients with good compliance, voluntarily signed the informed consent form andparticipated in the study.
  2. Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
  3. Stage (FIGO2018): IB3, IIA2, IIB-IVA;
  4. ECOG score: 0 ~ 1;
  5. The expected survival >6 months;
  6. The result of a pregnancy test (serum or urine) within seven days must be negative forwomen of childbearing age, who must take contraception during the trial.

Exclusion

Exclusion Criteria:

  1. Activity or uncontrol severe infection;
  2. Liver cirrhosis or other decompensated liver disease;
  3. A history of immune deficiency, including HIV positive or a congenitalimmunodeficiency disease;
  4. Chronic renal insufficiency or renal failure;
  5. Other malignancies were diagnosed within five years or needed treatments;
  6. Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
  7. The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
  8. A history of pelvic artery embolization;
  9. A history of pelvic radiotherapy;
  10. A history of partial hysterectomy or radical hysterectomy;
  11. A history of severe allergic reaction to platinum drugs;
  12. The drugs for the treatment of concomitant disease seriously impaired liver or kidneyfunction, such as tuberculosis;
  13. Patients who cannot understand the research regimen and refuse to sign the informedconsent form;
  14. Other concomitant diseases or special conditions seriously endanger the patient'shealth or interfere with the trial.

Study Design

Total Participants: 1956
Treatment Group(s): 2
Primary Treatment: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
Phase:
Study Start date:
June 27, 2022
Estimated Completion Date:
December 31, 2032

Study Description

All eligible patients will be divided into the following two treatment groups nonrandomly.

Image staging group: standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy+brachytherapy).

Surgery staging group: open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be conducted within 28 days postoperatively.)

Connect with a study center

  • Chongqing University Cancer Hospital

    Chongqing, Chongqing 400000
    China

    Active - Recruiting

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