The Efficacy of Adjuvant Chemotherapy in Locally Advanced Cervical Cancer

• 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.

• 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.

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