Clinical trial NCT04555226: The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)
Official title: Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Cancer
Keywords: Stage IIICr of cervical cancer
Lymph node dissection
Chemoradiation
PFS
Lead sponsor: Chongqing University Cancer Hospital
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jiangxi Provincial Cancer Hospital
name: Anhui Provincial Cancer Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Hebei Medical University Fourth Hospital
name: Zhejiang Cancer Hospital
name: Women's Hospital School Of Medicine Zhejiang University
name: Qilu Hospital of Shandong University
name: Fujian Cancer Hospital
name: Sichuan Cancer Hospital and Research Institute
name: Cancer Hospital of Guizhou Province
name: West China Second University Hospital
name: Tongji Hospital
name: The Affiliated Ganzhou Hospital of Nanchang University
name: First Affiliated Hospital of Gannan Medical University
name: Gansu Provincial Maternal and Child Health Care Hospital
name: Third Affiliated Hospital of Xinjiang Medical University
name: Affiliated Cancer Hospital of Shantou University Medical College
name: Obstetrics & Gynecology Hospital of Fudan University
name: The Second Affiliated Hospital of Dalian Medical University
name: Fujian Maternity and Child Health Hospital
First posted: 2020-09-18
Enrollment: 452
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an national, prospective, multicenter and randomized clinical study designed to determine if patients with stage IIICr of cervical cancer have longer PFS and/or OS with lymph node dissection before CCRT when compared to CCRT.

Detailed description: All eligible patients will be equally randomized between the 2 following treatment groups (stratified factors: whether para-aortic lymph nodes were image-positive):

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

Experimental group: open/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation. (Level of lymph node dissection: At least the inferior mesenteric artery. Chemoradiation will be performed postoperatively within 28 days.)

Eligibility criteria: Inclusion Criteria:

1. Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
2. Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
3. ECOG score 0\~1
4. Expected survival over 6 months
5. The serum or urine pregnancy test must be negative within 7 days before enrollment for the women of childbearing age who should agree that contraception must be used during the trial
6. No surgical contraindication

Exclusion Criteria:

1. Activity or uncontrol severe infection
2. Liver cirrhosis, Decompensated liver disease
3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
4. Chronic renal insufficiency or renal failure
5. Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
7. A history of pelvic artery embolization
8. A history of pelvic radiotherapy
9. A history of partial hysterectomy or radical hysterectomy
10. A history of severe allergic reaction to platinum drugs
11. During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Primary outcomes:
measure: PFS
timeFrame: 2 years
Secondary outcomes:
measure: OS
timeFrame: 3 and 5 years
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Cancer Hospital
state: Chongqing
Study officials:
affiliation: Chongqing University Cancer Hospital
name: Dongling Zou, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: de Sanjose S, Serrano B, Castellsague X, Brotons M, Munoz J, Bruni L, Bosch FX. Human papillomavirus (HPV) and related cancers in the Global Alliance for Vaccines and Immunization (GAVI) countries. A WHO/ICO HPV Information Centre Report. Vaccine. 2012 Nov 20;30 Suppl 4:D1-83, vi. doi: 10.1016/S0264-410X(12)01435-1. No abstract available.
citation: Chen W, Zheng R, Baade PD, Zhang S, Zeng H, Bray F, Jemal A, Yu XQ, He J. Cancer statistics in China, 2015. CA Cancer J Clin. 2016 Mar-Apr;66(2):115-32. doi: 10.3322/caac.21338. Epub 2016 Jan 25.
citation: Jolly S, Uppal S, Bhatla N, Johnston C, Maturen K. Improving Global Outcomes in Cervical Cancer: The Time Has Come for International Federation of Gynecology and Obstetrics Staging to Formally Incorporate Advanced Imaging. J Glob Oncol. 2018 Sep;4:1-6. doi: 10.1200/JGO.2016.007534. Epub 2017 Mar 21. No abstract available.
citation: 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;145(1):129-135. doi: 10.1002/ijgo.12749. Epub 2019 Jan 17.
citation: Goff BA, Muntz HG, Paley PJ, Tamimi HK, Koh WJ, Greer BE. Impact of surgical staging in women with locally advanced cervical cancer. Gynecol Oncol. 1999 Sep;74(3):436-42. doi: 10.1006/gyno.1999.5472.
citation: Kohler C, Mustea A, Marnitz S, Schneider A, Chiantera V, Ulrich U, Scharf JP, Martus P, Vieira MA, Tsunoda A. Perioperative morbidity and rate of upstaging after laparoscopic staging for patients with locally advanced cervical cancer: results of a prospective randomized trial. Am J Obstet Gynecol. 2015 Oct;213(4):503.e1-7. doi: 10.1016/j.ajog.2015.05.026. Epub 2015 May 15.
citation: 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):3026-33. doi: 10.1200/JCO.2012.47.3520. Epub 2013 Jul 15.
citation: Dag Z, Yilmaz B, Dogan AK, Aksan DU, Ozkurt H, Kizilkaya HO, Arslan D. Comparison of the prognostic value of F-18 FDG PET/CT metabolic parameters of primary tumors and MRI findings in patients with locally advanced cervical cancer treated with concurrent chemoradiotherapy. Brachytherapy. 2019 Mar-Apr;18(2):154-162. doi: 10.1016/j.brachy.2018.11.005. Epub 2018 Dec 26.
citation: Frumovitz M, Querleu D, Gil-Moreno A, Morice P, Jhingran A, Munsell MF, Macapinlac HA, Leblanc E, Martinez A, Ramirez PT. Lymphadenectomy in locally advanced cervical cancer study (LiLACS): Phase III clinical trial comparing surgical with radiologic staging in patients with stages IB2-IVA cervical cancer. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):3-8. doi: 10.1016/j.jmig.2013.07.007. Epub 2013 Jul 31.
citation: Gold MA, Tian C, Whitney CW, Rose PG, Lanciano R. Surgical versus radiographic determination of para-aortic lymph node metastases before chemoradiation for locally advanced cervical carcinoma: a Gynecologic Oncology Group Study. Cancer. 2008 May 1;112(9):1954-63. doi: 10.1002/cncr.23400.
citation: Cho WK, Kim YI, Park W, Yang K, Kim H, Cha H. Para-aortic lymph node recurrence after curative radiotherapy for cervical cancer. Int J Gynecol Cancer. 2019 Sep;29(7):1116-1120. doi: 10.1136/ijgc-2019-000615.
citation: Cosin JA, Fowler JM, Chen MD, Paley PJ, Carson LF, Twiggs LB. Pretreatment surgical staging of patients with cervical carcinoma: the case for lymph node debulking. Cancer. 1998 Jun 1;82(11):2241-8. doi: 10.1002/(sici)1097-0142(19980601)82:113.0.co;2-t.