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

NCT05378087RecruitingNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Chongqing University Cancer Hospital

Enrollment

1956

Start Date

2022-06-27

Completion Date

2027-04-30

Study Type

INTERVENTIONAL

Official Title

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

Interventions

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

Conditions

Locally Advanced Cervical Cancer

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

PFS

Progression-free survival

Time frame: 3 years

Secondary Outcomes

OS

3-year and 5-year Overall Survival

Time frame: 3 years and 5 years

Complication

Some conditions caused by surgery or chemoradiation.

Time frame: 1 year

Locations

Chongqing University Cancer Hospital, Chongqing, China

Linked Papers

2021-02-06

False negative rate at 18F-FDG PET/CT in para-aortic lymphnode involvement in patients with locally advanced cervical cancer: impact of PET technology

Abstract Background The identification of factors responsible for false negative (FN) rate at 18F- Fluorodeoxyglucose (FDG) Positron Emission Tomography /Computed Tomography (PET/CT) in para-aortic (PA) lymph nodes in the presurgical staging of patients with locally advanced cervical cancer (LACC) is challenging. The aim of this study was to evaluate the impact of PET/CT technology. Methods A total of 240 consecutive patients with LACC (International Federation of Gynecology and Obstetrics, FIGO, stage IB2-IVA) and negative Magnetic Resonance Imaging (MRI) and/or Computed Tomography (CT) and negative 18F-FDG PET/CT in the PA region, undergoing laparoscopic PA lymphadenectomy before chemoradiotherapy were included. The FN rate in patients studied with Time of flight (TOF) PET/CT (TOF PET) or non-Time of flight PET/CT (no-TOF PET) technology was retrospectively compared. Results Patients presented with FIGO stage IB (n = 78), stage IIA-B (n = 134), stage III (n = 18) and stage IVa (n = 10), squamous cell carcinoma (n = 191) and adenocarcinoma (n = 49). 141/240 patients were evaluated with no-TOF PET/CT and 99/240 with TOF PET/CT. Twenty-two patients (9%) had PA nodal involvement at histological analysis and considered PET/CT FN findings. The FN rate was 8.5% for no-TOF PET and 10% for TOF PET subgroup respectively (p = 0.98). Ninety patients (38%) presented with pelvic node uptakes at PET/CT. The FN rate in the PA region was 18% (16/90) and 4% (6/150) in patients with and without pelvic node involvement at PET/CT respectively (19 vs 3% for no-TOF PET and 17 vs 5% for TOF PET subgroup). Conclusions In LACC, FN rate in PA lymph nodes detection is a clinical issue even for modern PET/CT, especially in patients with pelvic uptake. Surgical lymphadenectomy should be performed in case of negative PET/CT at PA level in these patients, while it could be discussed in the absence of pelvic uptake.

2020-08-11

How should we stage and tailor treatment strategy in locally advanced cervical cancer? Imaging versus para-aortic surgical staging

Para-aortic lymph node status at initial assessment is the most important prognostic factor and a key point for the therapeutic strategy in patients with locally advanced cervical cancer. Undiagnosed lymph node metastasis is a major clinical problem as the finding of positive para-aortic lymph nodes leads to treatment modification, with a possible impact on disease free survival. When aortic lymph node disease is discovered, radiotherapy is extended to the para-aortic area, and other treatment modalities may be considered. Fluorine-18 fluorodeoxyglucose positron emission tomography/computed tomography (PET/CT) is the most accurate imaging examination to assess para-aortic extension in patients with locally advanced cervical cancer. The gold standard to identify para-aortic extension remains histologic evaluation of the lymph nodes. Indeed, PET/CT fails to detect approximately 10-15% of patients with negative PET/CT aortic nodes who have lymph node metastasis on pathologic staging. Patients with positive pelvic lymph nodes have para-aortic extension in 25-30% of cases, and surgical staging will lead to treatment modification and probably to improved para-aortic and distant control. Surgical staging also avoids unnecessary toxicity associated with extended field radiation in approximately 75% of patients with pelvic lymph node metastasis. The best modality to identify para-aortic extension is histological evaluation of the lymph nodes, but the survival benefit of surgical staging remains controversial. On the other hand, current studies include a majority of patients without pelvic lymph node spread, who are likely to be those who will benefit the least from surgical staging.