Comparison of Different Subsequent Treatments After Radical Surgery

Cervical Cancer Clinical Trial

— STARS  

Official title:

Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00806117
• Other study ID #: SYSU50102008049
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: February 25, 2008
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2019
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1080
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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
• Sequence chemotherapy and radiotherapy (SCRT)
Paclitaxel 135~175mg/m2 over 3 hours Cisplatin 60~75mg/m2

Locations

Country	Name	City	State
China	Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (5)

Lead Sponsor	Collaborator
Sun Yat-sen University	Cancer Hospital of Guangxi Medical University, First Affiliated Hospital, Sun Yat-Sen University, Guangdong Provincial People's Hospital, Shenzhen People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival	DFS survival analysis	3-Yr
Secondary	Overall Survival	OS survival analysis	5-Yr