A Multicenter Trial of Benefits of Adding Post-surgery Chemotherapy for Cervical Cancer

Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of the survival over years. The risk of recurrence after radical surgery has increased with positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy can improve the overall survival rate of patients with adverse pathological prognostic factors is inconclusive.

In this study, in order to investigate the effect and adverse reaction of chemotherapy as the adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine hundred and ninety patients will be randomly divided into three groups, comparing radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The investigators aim to find out the best therapeutic regimen with lowest adverse reaction for cervical cancer with adverse pathological prognostic factors. To guide clinical treatment options.

• Radiation: Radiotherapy

  External irradiation 50Gy/5 weeks

  • Lateral: 2 cm lateral to the bony margin of the pelvis
  • Superior: Between L5 and S1
  • Inferior: 2 cm below the obturator foramen Intracavitary boost 30-35Gy/4 weeks(positive vaginal margins only)
• Drug: Cisplatin
  Cisplatin 40mg/m2 every week during external irradiation
• Drug: Paclitaxel+Cisplatin
  Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2

• Active Comparator: A
  Radiotherapy
  Intervention: Radiation: Radiotherapy
• Experimental: B

  Concurrent chemoradiation:

  External beam radiation with concurrent weekly platinum chemotherapy

  Interventions:

  • Radiation: Radiotherapy
  • Drug: Cisplatin
• Experimental: C

  Sequence chemotherapy and radiotherapy:

  2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

  Interventions:

  • Radiation: Radiotherapy
  • Drug: Paclitaxel+Cisplatin

Inclusion Criteria:

• Patients with newly histologically confirmed cervical carcinoma
• Original clinical stage must be Ib~IIa （FIGO）
• Age between 18-65
• With the presence of these four factors after radical surgery:(1)positive lymph nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic vascular space,(4)outer one-third invasion of the cervical stroma
• More than 3 months survival is to expect
• Patients must give signed informed consent

Exclusion Criteria:

• The presence of uncontrolled life-threatening illness
• Receiving other ways of anti-cancer therapy
• Residual tumor which can not be removed in the surgery
• Investigator consider the patients can't finish the whole study
• With normal liver function test (ALT、AST>2.5×ULN)
• With normal renal function test (Creatinine>1.5×ULN)
• WBC<4,000/mm3 or PLT<100,000/mm3
• Receive the external pelvic irradiation before the surgery