RecruitingNot ApplicableNCT05378087

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

Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer


Sponsor

Chongqing University Cancer Hospital

Enrollment

1,956 participants

Start Date

Jun 27, 2022

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two ways to stage locally advanced cervical cancer — surgical staging versus imaging (CT/MRI/PET-CT) — to see which better guides treatment. **You may be eligible if...** - You have locally advanced cervical cancer (stages IB3–IVA) confirmed by biopsy - Your cancer is squamous cell, adenocarcinoma, or adenosquamous type - Your performance status is good (ECOG 0–1) - You have a negative pregnancy test if you are of childbearing age **You may NOT be eligible if...** - You have an uncontrolled serious infection - You have liver disease, HIV, immune deficiency, or severe kidney/heart problems - You have another active cancer - You have had pelvic radiation, pelvic artery embolization, or hysterectomy before - Your lymph nodes along the main aorta (para-aortic) are already positive on imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONConcurrent chemoradiation

Standard concurrent chemoradiation: A point/HCR-CTV D90 ≥80Gy (+20%) by using IMRT or TOMO technics. Patients with image-positive common iliac lymph nodes or para-aortic lymph nodes receive extended-field EBRT. Brachytherapy should begin after 15-20F external radiotherapy. A radiation dose for the image-positive nodes can range from 55Gy to 60Gy. Five cycles of concurrent platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period one week) and CCRT should be completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 ≤ 96Gy).

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

Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation. (height of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation should be performed postoperatively within 28 days.) The chemoradiation is consistent with the image staging group, except for extended-field EBRT determined by pathological positive para-aortic lymph nodes.


Locations(1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

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NCT05378087


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