Cervical Cancer
Conditions
Keywords
Locally adcanced, CCRT, Adjuvant chemotherapy
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. 2. Patients: 1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%), B点50Gy(+/-10%), concurrent platinum-containing chemotherapy（cisplatin or carboplatin） 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 3. 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.
Interventions
RADIATIONCCRT
Radiation concurrent platinum-containing chemotherapy (cisplatin or carboplatin)
The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
Sponsors
Chongqing University Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Cervical cancer stage IIb to IVa with histopathology of squamous cell carcinoma, adenosquamous cell carcinoma, adenocarcinoma 2. Complete CCRT(Radiation Does: A point 85Gy(+/-10%)，B点50Gy(+/-10%)，concurrent platinum-containing chemotherapy (cisplatin or carboplatin)) 3. MRI is performed within 4 weeks after CCRT and shows residual lesions (non-lymph node≥10mm, lymph node shortest diameter≥15mm). 4. ECOG\<2 5. Expected survival is longer than six months 6. Hb≥70g/L、WBC≥3.5×109/ L 、ANC≥1.5×109/L、PLT≥80×109/L 7. ALT and AST≤2×ULN, Serum creatinine≤1.5×ULN 8. 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
1. Activity or uncontrol severe infection 2. Liver cirrhosis, Decompensated liver disease 3. History of immune deficiency, including HIV positive or suffering from congenital immunodeficiency disease 4. Patients who cannot tolerate chemotherapy because of chronic renal insufficiency or renal failure 5. Have suffered or combined with other malignant tumor 6. Myocardial infarction, severe arrhythmia and NYHA (New York heart association)≥2 for congestive heart failure 7. A history targeted therapy or pelvic artery embolization 8. Artery-enous thrombosis within 6 months 9. Patients with autoimmune diseases 10. Complications, need to be treatment with drugs which may lead to liver or kidney injury 11. Patients with disease progression after chemoradiation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | 2 years | Progression-free survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | 5 years | 5 years overall survival |
| ORR | 3 months | To evaluate the objective response rate(CR+PR) of adjuvant chemotherapy in cervical cancer |
Countries
China
Contacts
Primary ContactDongling Zou, M.D.
Outcome results
None listed