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 a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%)B50Gy(+/-10%)concurrent paclitaxel and cisplatin once a week for six cycles)
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node10mmlymph node shortest diameter15mm).
- 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 a histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma
- Complete CCRT(Radiation Does: A point 85Gy(+/-10%)B50Gy(+/-10%)concurrent paclitaxel and cisplatin once a week for six cycles)
- MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node10mmlymph node shortest diameter15mm).
- ECOG2
- Expected survival is longer than six months
- Hb70g/LWBC3.5109/ L ANC1.5109/LPLT80109/L
- ALT and AST2ULN, Serum creatinine1.5ULN
- 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