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Clinical Trials/NCT04555226
NCT04555226RecruitingNot Applicable

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

Chongqing University Cancer Hospital2 sites in 1 country452 target enrollmentStarted: January 11, 2021Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
452
Locations
2
Primary Endpoint
PFS
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 ±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.)

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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
  • •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

Outcomes

Primary Outcomes

PFS

Time Frame: 2 years

Progression-free survival

Secondary Outcomes

  • OS(3 and 5 years)

Investigators

Sponsor
Chongqing University Cancer Hospital
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dongling Zou

Director of Gynecologic Oncology Department

Chongqing University Cancer Hospital

Study Sites (2)

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The Efficacy of Lymph Node Dissection for... | Clinical Trial