Recruiting NCT05378087
Comparing the Efficacy of Surgery Staging and Image Staging of Locally Advanced Cervical Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concurrent chemoradiation, Open/minimally invasive para-aortic lymph node dissection followed by concurrent chemoradiation.
- Who it may be relevant to
- Registry conditions: Locally Advanced Cervical Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Non-randomized Concurrent Controlled Trial of Surgery Staging or Image Staging of Locally Advanced Cervical Cancer
Overview
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.)
Interventions
- 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 - 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.
Primary outcome measures
- PFS [Time frame: 3 years]
Secondary outcome measures (2)
- OS [Time frame: 3 years and 5 years]
- Complication [Time frame: 1 year]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Chongqing University Cancer Hospital — Chongqing
Publications
- Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338
- Bhatla N, Berek JS, Cuello Fredes M, Denny LA, Grenman S, Karunaratne K, Kehoe ST, Konishi I, Olawaiye AB, Prat J, Sankaranarayanan R, Brierley J, Mutch D, Querleu D, Cibula D, Quinn M, Botha H, Sigurd L, Rice L, Ryu HS, Ngan H, Maenpaa J, Andrijono A, Purwoto G, Maheshwari A, Bafna UD, Plante M, Natarajan J. Revised FIGO staging for carcinoma of the cervix uteri. Int J Gynaecol Obstet. 2019 Apr;1 PMID 30656645
- Martinez A, Angeles MA, Querleu D, Ferron G, Pomel C. How should we stage and tailor treatment strategy in locally advanced cervical cancer? Imaging versus para-aortic surgical staging. Int J Gynecol Cancer. 2020 Sep;30(9):1434-1443. doi: 10.1136/ijgc-2020-001351. Epub 2020 Aug 11. PMID 32788263
- Choi HJ, Ju W, Myung SK, Kim Y. Diagnostic performance of computer tomography, magnetic resonance imaging, and positron emission tomography or positron emission tomography/computer tomography for detection of metastatic lymph nodes in patients with cervical cancer: meta-analysis. Cancer Sci. 2010 Jun;101(6):1471-9. doi: 10.1111/j.1349-7006.2010.01532.x. Epub 2010 Feb 11. PMID 20298252
- Kang S, Kim SK, Chung DC, Seo SS, Kim JY, Nam BH, Park SY. Diagnostic value of (18)F-FDG PET for evaluation of paraaortic nodal metastasis in patients with cervical carcinoma: a metaanalysis. J Nucl Med. 2010 Mar;51(3):360-7. doi: 10.2967/jnumed.109.066217. Epub 2010 Feb 11. PMID 20150275
- Gouy S, Seebacher V, Chargari C, Terroir M, Grimaldi S, Ilenko A, Maulard A, Genestie C, Leary A, Pautier P, Morice P, Deandreis D. False negative rate at 18F-FDG PET/CT in para-aortic lymphnode involvement in patients with locally advanced cervical cancer: impact of PET technology. BMC Cancer. 2021 Feb 6;21(1):135. doi: 10.1186/s12885-021-07821-9. PMID 33549033
- Gouy S, Morice P, Narducci F, Uzan C, Martinez A, Rey A, Bentivegna E, Pautier P, Deandreis D, Querleu D, Haie-Meder C, Leblanc E. Prospective multicenter study evaluating the survival of patients with locally advanced cervical cancer undergoing laparoscopic para-aortic lymphadenectomy before chemoradiotherapy in the era of positron emission tomography imaging. J Clin Oncol. 2013 Aug 20;31(24):302 PMID 23857967
- Gouy S, Morice P, Narducci F, Uzan C, Gilmore J, Kolesnikov-Gauthier H, Querleu D, Haie-Meder C, Leblanc E. Nodal-staging surgery for locally advanced cervical cancer in the era of PET. Lancet Oncol. 2012 May;13(5):e212-20. doi: 10.1016/S1470-2045(12)70011-6. PMID 22554549
Identifiers
NCT: NCT05378087 · CQGOG0106