The Efficacy of Lymph Node Dissection for Stage IIICr of Cervical Cancer(CQGOG0103)
Recruiting now · Not applicable
Conditions studied: Cervical Cancer
In brief
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.
Key facts
- Study ID
- NCT04555226
- Run by
- Chongqing University Cancer Hospital
- People needed
- 452
- Starts
- 2021-01-11
- Expected to finish
- 2032-08-01
- Last updated by the study team
- 2025-09-02
Who can join
Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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