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Clinical Trials in China / NCT04409860
Recruiting Not applicable

The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

NCT04409860 · tracked via the Priya Life Science China tracker
Sponsor
Chongqing University Cancer Hospital
Phase
Not applicable
Started
2020-05-26
Last updated
2023-04-11

Condition(s) studied

Cervical Cancer

Investigational drug(s) / intervention(s)

CCRTPaclitaxel, Cisplatin

CCRT: Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)

Paclitaxel, Cisplatin: The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.

Study summary

The aim of this trial was to evaluate the efficacy of adjuvant chemotherapy in the locally advanced cervical cancer with residual lesions after concurrent chemoradiation therapy.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%),B点50Gy(+/-10%),concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 4. ECOG\<2 5. Expected survival is longer than six months 6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L 7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN 8. 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 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. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure 5. Have suffered or combined with other malignant tumor 6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 7. A history targeted therapy or pelvic artery embolization 8. Artery-enous thrombosis within 6 months 9. Patients with autoimmune diseases 10. Complications, need to be treatment with drugs which may lead to liver or kidney injury 11. Patients with disease progression after chemoradiation

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Chongqing Cancer Hospital Chongqing Chongqing Municipality Recruiting

More Chongqing University Cancer Hospital trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04409860 on ClinicalTrials.gov ↗ ← All trials in China