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

Locally Advanced Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05378087
• Other study ID #: CQGOG0106
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2022
• Est. completion date: December 31, 2032

Study information

• Verified date: August 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

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.

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.)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1956
• Est. completion date: December 31, 2032
• Est. primary completion date: April 30, 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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 completed within 56 days. CCRT one week later, if the cervix biopsy shows residual tumour and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes in the pelvic and abdominal cavity, three cycles of adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy will be performed (A point/HR-CTV D90 = 96Gy).

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.

Locations

Country	Name	City	State
China	Chongqing University Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Chongqing University 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

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. — 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

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, 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. — 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

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. — View Citation

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. Erratum In: J Nucl Med. 2010 Aug;51(8):1327. — 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

Lai CH, Huang KG, Hong JH, Lee CL, Chou HH, Chang TC, Hsueh S, Huang HJ, Ng KK, Tsai CS. Randomized trial of surgical staging (extraperitoneal or laparoscopic) versus clinical staging in locally advanced cervical cancer. Gynecol Oncol. 2003 Apr;89(1):160-7. doi: 10.1016/s0090-8258(03)00064-7. — View Citation

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. — View Citation

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. — 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	3 years
Secondary	OS	3-year and 5-year Overall Survival	3 years and 5 years
Secondary	Complication	Some conditions caused by surgery or chemoradiation.	1 year