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NCT Number: NCT05378087

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

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

Location status: Recruiting

Location contact

Dongling Zou, M.D.

CONTACT

[email protected]

13657690699

About this study

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.)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patients with good compliance, voluntarily signed the informed consent form and participated in the study.
  • Histopathology: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
  • Stage (FIGO2018): IB3, IIA2, IIB-IVA;
  • ECOG score: 0 ~ 1;
  • The expected survival >6 months;
  • 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

  • Activity or uncontrol severe infection;
  • Liver cirrhosis or other decompensated liver disease;
  • A history of immune deficiency, including HIV positive or a congenital immunodeficiency disease;
  • Chronic renal insufficiency or renal failure;
  • Other malignancies were diagnosed within five years or needed treatments;
  • Myocardial infarction, severe arrhythmia and congestive heart failure with grade ≥2 (New York heart association);
  • The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
  • A history of pelvic artery embolization;
  • A history of pelvic radiotherapy;
  • A history of partial hysterectomy or radical hysterectomy;
  • A history of severe allergic reaction to platinum drugs;
  • The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
  • Patients who cannot understand the research regimen and refuse to sign the informed consent form;
  • Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.

Treatment and study plan

Concurrent Chemoradiation

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).

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

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.

Primary outcomes

  1. PFS

    Time frame: 3 years

    Progression-free survival

Secondary outcomes

  1. OS

    Time frame: 3 years and 5 years

    3-year and 5-year Overall Survival

  2. Complication

    Time frame: 1 year

    Some conditions caused by surgery or chemoradiation.

Study contacts

Contact information is provided by the study sponsor or research team.

Dongling Zou, M.D.

CONTACT

[email protected]

13657690699

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2032
First posted
May 17, 2022
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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