Comparison of Different Subsequent Treatments After Radical Surgery

Summary

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.

Conditions

• Cervical Cancer

Interventions

RADIATION

Radiotherapy (RT)

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)

OTHER

Concurrent chemoirradiation (CCRT)

Cisplatin 40mg/m2 every week during external irradiation

OTHER

Sequence chemotherapy and radiotherapy (SCRT)

Paclitaxel 135\~175mg/m2 over 3 hours Cisplatin 60\~75mg/m2

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• First Affiliated Hospital, Sun Yat-Sen University

  collaborator OTHER

• Shenzhen People's Hospital

  collaborator OTHER

• Cancer Hospital of Guangxi Medical University

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Principal Investigators

• Jihong Liu, Ph.D. · Sun Yat-sen University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-02-25

Primary Completion

2018-12-31

Completion

2020-12-31

Countries

• China

Study Locations