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

NCT ID: NCT05378087

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1956 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-27
• Study Completion Date: 2032-12-31

Brief 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.

Detailed 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.)

Conditions

Locally Advanced Cervical Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Image staging group

Standard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Group Type: ACTIVE_COMPARATOR

Concurrent chemoradiation

Intervention Type: RADIATION

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).

Surgery staging group

Open/minimally invasive para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy).

Group Type: EXPERIMENTAL

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

Intervention Type: PROCEDURE

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.

Interventions

Concurrent 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).

Intervention Type: RADIATION

Open/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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. The patients with good compliance, voluntarily signed the informed consent form and participated 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 for women of childbearing age, who must take contraception during the trial.

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 congenital immunodeficiency 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 kidney function, such as tuberculosis;

13. Patients who cannot understand the research regimen and refuse to sign the informed consent form;

14. Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dongling Zou

Director of Gynecologic Oncology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dongling Zou, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chongqing University Cancer Hospital

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dongling Zou, M.D.

Role: CONTACT

cqzl_zdl@163.com

13657690699

Facility Contacts

Dongling Zou, M.D.

Role: primary

cqzl_zdl@163.com

13657690699

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Other Identifiers

CQGOG0106

Identifier Type: -

Identifier Source: org_study_id