Comparison of Post-surgery Adjuvant Therapy for Cervical Carcinoma
|ClinicalTrials.gov Identifier: NCT00806117|
Recruitment Status : Active, not recruiting
First Posted : December 10, 2008
Last Update Posted : March 27, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Radiation: Radiotherapy (RT) Other: Concurrent chemoirradiation (CCRT) Other: Sequence chemotherapy and radiotherapy (SCRT)||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1080 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
After radical surgery, eligible patients with risk pathological factors were randomize to three groups.
Radiotherapy: Group A underwent 50 GY pelvic RT alone. Radiotherapy and drugs: Group B received concurrent weekly cisplatin and RT (CCRT).
Radiotherapy and drugs: Group C received paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two cycles of chemotherapy (SCRT).
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma|
|Actual Study Start Date :||February 25, 2008|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Active Comparator: Radiotherapy (RT)
Radiation: Radiotherapy (RT)
External irradiation 50Gy/5 weeks
Experimental: Concurrent chemoirradiation (CCRT)
External beam radiation with concurrent weekly platinum chemotherapy
Other: Concurrent chemoirradiation (CCRT)
Cisplatin 40mg/m2 every week during external irradiation
Experimental: Sequence chemo and radiation (SCRT)
Sequence chemotherapy and radiotherapy:
2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation
Other: Sequence chemotherapy and radiotherapy (SCRT)
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2
- Disease Free Survival [ Time Frame: 3-Yr ]DFS survival analysis
- Overall Survival [ Time Frame: 5-Yr ]OS survival analysis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00806117
|Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center|
|Guangzhou, Guangdong, China, 510060|
|Study Chair:||Jihong Liu, Ph.D.||Sun Yat-sen University|