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AzTrials

Cervical CancerNCT04555226

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

A study testing Lymph node dissection, Standard chemoradiation±pembrolizumab and Chemoradiation± pembrolizumab in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Cervical Cancer
What is being tested?
Lymph node dissection, Standard chemoradiation±pembrolizumab and Chemoradiation± pembrolizumab
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
452 participants
Where
1 siteChina
Study dates
11 Jan 2021to Aug 2032
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histopathology: squamous cell carcinoma, adenocarcinoma, adeno-squamous cell carcinoma
  • Cervical cancer stage IIICr (confirmed by CT/MRI/PET/CT) and the short diameter of image-positive lymph node ≥15mm
  • ECOG score 0~1
  • Expected survival over 6 months
  • 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
  • No surgical contraindication

Who cannot join

  • Activity or uncontrol severe infection
  • Active hepatitis B, Liver cirrhosis, Decompensated liver disease
  • History of immune deficiency, including HIV positive or suffering from other immunodeficiency disease
  • Active autoimmune disease requiring systemic treatment (e.g., use of disease-modifying medications, corticosteroids, or immunosuppressive medications). Replacement therapies (e.g., thyroxine, insulin, or physiological corticosteroid replacement for adrenal or pituitary insufficiency) were not counted as systemic therapies, and subjects were permitted to use these therapies
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
  • Chronic renal insufficiency or renal failure
Show all 15Show fewer
  • Has combined with other malignant tumor which diagnosed within 5 years and/or needed to be treated
  • Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
  • Has had an allogenic tissue/solid organ transplant
  • A history of pelvic artery embolization
  • A history of pelvic radiotherapy
  • A history of partial hysterectomy or radical hysterectomy
  • A history of immunotherapy or undergoing immunotherapy
  • A history of severe allergic reactions to platinum-based chemotherapy drugs, pembrolizumab and/or any excipients
  • During the treatment for complications, the drugs which lead to serious liver and/or kidney function impairment need to be used, such as tuberculosis

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dongling Zou, M.D. contact

13657690699

cqzl_zdl@163.com

China1 site, 1 recruiting

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality, 400030

    Dongling Zou, M.D., 13657690699, cqzl_zdl@163.com

    Dongling Zou, M.D.

    Recruiting

Other trials in China

About this study

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

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.

Read the 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 ±pembrolizumab).

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

Conditions
Cervical Cancer
Being tested
Lymph node dissection, Standard chemoradiation±pembrolizumab, Chemoradiation± pembrolizumab
Keywords
Stage IIICr of cervical cancer, Lymph node dissection, Chemoradiation, PFS
Medical subject headings
Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lymph node dissectionProcedure or surgery

    Open/minimaly invasive pelvic and para-aortic lymph node dissection

  • Standard chemoradiation±pembrolizumabRadiation

    1. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.

  • Chemoradiation± pembrolizumabRadiation

    1. A point/HCR-CTV D90≥80Gy(+20%).2. Extended-field EBRT: image-positive common iliac LN with SD≥10mm and/or image-positive PALN.3. Target doses for the image-positive nodes can range from 55 to 60Gy.4. Concurrent 5 cycles platinum-containing chemotherapy(Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w).5. CCRT will be completed in 56 days.6. The patients who received combined immunotherapy were treated with pembrolizumab (200mg, q3w, 3 cycles) during CCRT.7.After CCRT if the cervix biopsy shows residual tumor and/or imaging indicates that there are still positive LN with SD≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TAX 135mg/m2, DDP 50mg/m2, q3w or TAX 135mg/m2, CBP AUC=4, q3W) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) ± pembrolizumab(suitable for the patients who combined immunotherapy,200mg, q3w, 3 cycles) will be performed.8.Maintenance treatment with pembrolizumab (400mg, q6w) is optional for the combined immunotherapy patiants.
Study groups in NCT04555226
Study groupRoleWhat they receive
Standard treatment groupActive comparatorStandard chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Receives: Radiation: Standard chemoradiation±pembrolizumab
Experimental groupExperimentalOpen/minimally invasive pelvic and para-aortic lymph node dissection followed by chemoradiation (Pelvic EBRT/Extended-field EBRT + concurrent platinum-containing chemotherapy + brachytherapy±pembrolizumab).
Receives: Procedure: Lymph node dissection; Radiation: Chemoradiation± pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PFS

    Progression-free survival

    Measured: 2 years

Secondary outcomes (1)

  1. OS

    Overall survival

    Measured: 3 and 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2020
  2. Study start11 Jan 2021
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
452 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04555226
Sponsor's protocol ID
CQGOG0103
Status last verified
Aug 2025
First submitted
14 Sep 2020
Last updated
2 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 23510764

  • 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.

    PubMed 26808342

  • 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.

    PubMed 30241155

  • 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.

    PubMed 30656645

  • 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.

    PubMed 10479506

  • 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.

    PubMed 25986030

  • 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.

    PubMed 23857967

  • 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.

    PubMed 30594422

  • 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.

    PubMed 23911560

  • 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.

    PubMed 18338811

  • 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.

    PubMed 31474588

  • 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.

    PubMed 9610705

  • He M, Guo M, Zhou Q, Tang Y, Zhong L, Liu Q, Fan X, Zhao X, Zhang X, Chen G, Shen Y, Xu Q, Chen X, Li Y, Zou D. Efficacy of lymph node dissection on stage IIICr of cervical cancer before CCRT: study protocol for a phase III, randomized controlled clinical trial (CQGOG0103). J Gynecol Oncol. 2023 May;34(3):e55. doi: 10.3802/jgo.2023.34.e55. Epub 2023 Mar 23.

    PubMed 36998225

Questions about this trial

What is this clinical trial studying?

A study testing Lymph node dissection, Standard chemoradiation±pembrolizumab and Chemoradiation± pembrolizumab in people with Cervical Cancer, run by Chongqing University Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dongling Zou, M.D. (13657690699, cqzl_zdl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PFS (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04555226, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.

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