The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)

Cervical Cancer Clinical Trial

Official title:

Randomized Controlled Trial of the Efficacy of Lymph Node Dissection on Stage IIICr of Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04555226
• Other study ID #: CQGOG0103
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2021
• Est. completion date: August 2029

Study information

• Verified date: September 2023
• Source: Chongqing University Cancer Hospital
• Contact: Dongling Zou, M.D.
• Phone: 13657690699
• Email: cqzl_zdl[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 452
• Est. completion date: August 2029
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Lymph node dissection
Open/minimaly invasive pelvic and para-aortic lymph node dissection

Radiation:
• Standard chemoradiation
A point/HCR-CTV D90 =80Gy(+20%) Extended-field EBRT: image-positive common iliac lymph nodes with short diameter =10mm and/or image-positive para-aortic lymph node Target doses for the image-positive nodes can range from 55 to 60Gy Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter =15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.
• Chemoradiation
A point/HCR-CTV D90 =80Gy(+20%) Extended-field EBRT: Pathlogical positive para-aortic lymph node Target doese for pelvic and/or abdomal lymph nodes is usually 45Gy. After operation, the residual lymph node need to be labeled and the target doses for it ranges from 55-60Gy. Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week) CCRT will be completed in 56 days After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter =15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed.

Locations

Country	Name	City	State
China	Chongqing Cancer Hospital	Chongqing	Chongqing

Sponsors (23)

Lead Sponsor

Collaborator

Chongqing University Cancer Hospital

Affiliated Cancer Hospital of Shantou University Medical College, Anhui Provincial Cancer Hospital, Cancer Hospital of Guizhou Province, First Affiliated Hospital of Gannan Medical University, Fujian Cancer Hospital, Fujian Maternity and Child Health Hospital, Gansu Provincial Maternal and Child Health Care Hospital, Hebei Medical University Fourth Hospital, Jiangxi Provincial Cancer Hospital, Obstetrics & Gynecology Hospital of Fudan University, Qilu Hospital of Shandong University, Sichuan Cancer Hospital and Research Institute, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-sen University, The Affiliated Ganzhou Hospital of Nanchang University, The Second Affiliated Hospital of Dalian Medical University, The Second Affiliated Hospital of Harbin Medical University, Third Affiliated Hospital of Xinjiang Medical University, Tongji Hospital, West China Second University Hospital, Women's Hospital School Of Medicine Zhejiang University, Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

References & Publications (12)

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. Erratum In: Int J Gynaecol Obstet. 2019 Nov;147(2):279-280. — View Citation

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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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	2 years
Secondary	OS	Overall survival	3 and 5 years