NCT05378087Recruiting
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
Source: ClinicalTrials.gov · Last updated 31 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1956 (estimated)
- First submitted
- 12 May 2022
- Start date
- 27 Jun 2022
- Primary completion date
- 30 Apr 2027
- Lead sponsor
- Chongqing University Cancer Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT05378087
What you commit to
- Study type: Interventional
- Planned participants: 1956
- From 27 Jun 2022 to the primary completion date, 30 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The drugs for the treatment of concomitant disease seriously impaired liver or kidney function, such as tuberculosis;
- Other concomitant diseases or special conditions seriously endanger the patient's health or interfere with the trial.
Other illness
- 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);
- 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;
Other
- The CT/MRI/PET/CT show that the para-aortic lymph nodes are positive;
- Patients who cannot understand the research regimen and refuse to sign the informed consent form;
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chongqing University Cancer Hospital Coordinator of this site? Confirm its status | Chongqing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.