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

Sponsor
Chongqing University Cancer Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05378087
Collaborator
(none)
1,956
Enrollment
1
Location
2
Arms
126.3
Anticipated Duration (Months)
15.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Radiation: Concurrent chemoradiation
  • Procedure: Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation
 N/A

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.)

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1956 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
This is a non-randomized controlled concurrent trial. According to the patients' voluntary choice, they are enrolled on the surgery staging group or image staging group. All patients are evaluated by CT(≥32 slices) or MRI(≥1.5T) or PET/CT. The criteria for positive pelvic or para-aortic lymph nodes (one of the following): ① CT or MRI show more than one positive lymph node with a short diameter ≥ 15mm; ② PET/CT shows more than one positive lymph node with SUV ≥ 2.5; ③ If CT or MRI show positive lymph node with a short diameter between 10mm and 15mm, PET / CT should further verify that it is a positive lymph node with SUV ≥ 2.5.This is a non-randomized controlled concurrent trial. According to the patients' voluntary choice, they are enrolled on the surgery staging group or image staging group. All patients are evaluated by CT(≥32 slices) or MRI(≥1.5T) or PET/CT. The criteria for positive pelvic or para-aortic lymph nodes (one of the following): ① CT or MRI show more than one positive lymph node with a short diameter ≥ 15mm; ② PET/CT shows more than one positive lymph node with SUV ≥ 2.5; ③ If CT or MRI show positive lymph node with a short diameter between 10mm and 15mm, PET / CT should further verify that it is a positive lymph node with SUV ≥ 2.5.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
Anticipated Study Start Date :
Jun 22, 2022
Anticipated Primary Completion Date :
Apr 30, 2027
Anticipated Study Completion Date :
Dec 31, 2032

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Image staging group

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

Radiation: 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).
Experimental: Surgery staging group

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

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. PFS [3 years]

    Progression-free survival

Secondary Outcome Measures

  1. OS [3 years and 5 years]

    3-year and 5-year Overall Survival

  2. Complication [1 year]

    Some conditions caused by surgery or chemoradiation.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chongqing University Cancer Hospital Chongqing Chongqing China 400000

Sponsors and Collaborators

  • Chongqing University Cancer Hospital

Investigators

  • Principal Investigator: Dongling Zou, M.D., Chongqing University Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
ClinicalTrials.gov Identifier:
NCT05378087
Other Study ID Numbers:
  • CQGOG0106
First Posted:
May 17, 2022
Last Update Posted:
May 17, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dongling Zou, Director of Gynecologic Oncology Department, Chongqing University Cancer Hospital
surgery staging
image staging
Locally advanced cervical cancer
PFS
Additional relevant MeSH terms:
Uterine Cervical Neoplasms

Study Results

No Results Posted as of May 17, 2022