Status:
RECRUITING
The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer
Lead Sponsor:
Chongqing University Cancer Hospital
Conditions:
Cervical Cancer
Eligibility:
FEMALE
18-75 years
Phase:
NA
Brief 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.
Detailed Description
1. Objective: To compare response rate and survivals of locally advanced stage cervical cancer patients with residual lesions who had CCRT alone to those who had adjuvant chemotherapy after CCRT. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04409860
Start Date
May 26 2020
End Date
April 1 2029
Last Update
April 11 2023
Active Locations (1)
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1
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030