Overview
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.
Description
- 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.
2. Patients:
- 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).
- Methods:
The patients who have residual lesions after CCRT are randomized to arm A by observation or arm B by adjuvant chemotherapy with paclitaxel plus cisplatin every 3 weeks for 3 cycles.
Eligibility
Inclusion Criteria:
- 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 Criteria:
- 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