RecruitingNot ApplicableNCT04409860
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Randomized Controlled Trial of the Efficacy of Adjuvant Chemotherapy in Patients With Residual Lesions After Concurrent Radiochemotherapy for Locally Advanced Cervical Cancer
Sponsor
Chongqing University Cancer Hospital
Enrollment
120 participants
Start Date
May 26, 2020
Study Type
INTERVENTIONAL
Conditions
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: FEMALEMin Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin))
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm).
- ECOG\<2
- Expected survival is longer than six months
- Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L
- ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN
- 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 Criteria11
- Activity or uncontrol severe infection
- Liver cirrhosis, Decompensated liver disease
- History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease
- Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure
- Have suffered or combined with other malignant tumor
- Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure
- A history targeted therapy or pelvic artery embolization
- Artery-enous thrombosis within 6 months
- Patients with autoimmune diseases
- Complications, need to be treatment with drugs which may lead to liver or kidney injury
- Patients with disease progression after chemoradiation
Interventions
RADIATIONCCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
DRUGPaclitaxel, Cisplatin
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04409860
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