A Multicenter Trial of Benefits of Adding Post-surgery Chemotherapy for Cervical Cancer
Conditions
Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical cancer, Concurrent chemoradiation, Randomized controlled clinical trials
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Intervention
Name: Radiotherapy (RT) Type: Radiation
Name: Concurrent chemoirradiation (CCRT) Type: Other
Name: Sequence chemotherapy and radiotherapy (SCRT) Type: Other
Overall Status
Recruiting
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.
Detailed Description
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more following pathological factors were recruited: lymph node metastases (LNM), positive parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent 50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles.

We have recruited 800 patients till November 2014.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 65 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
Location
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Status: Recruiting
Contact: Jihong Liu, Ph.D. - 86-20-87343102 - Liujih@mail.sysu.edu.cn
Start Date
February 2008
Completion Date
December 2018
Sponsors
Sun Yat-sen University
Source
Sun Yat-sen University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page