Comparison of Different Subsequent Treatments After Radical Surgery (STARS)

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Cervical Cancer

Treatments: Other: Sequence chemotherapy and radiotherapy (SCRT); Radiation: Radiotherapy (RT); Other: Concurrent chemoirradiation (CCRT)

Study type: Interventional

Funder types: Other

Identifiers

NCT00806117

SYSU50102008049

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,080 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,080 participants in 3 patient groups

Radiotherapy (RT)

Active Comparator group

Description:

Radiotherapy

Treatment:

Radiation: Radiotherapy (RT)

Concurrent chemoirradiation (CCRT)

Experimental group

Description:

Concurrent chemoirradiation: External beam radiation with concurrent weekly platinum chemotherapy

Treatment:

Other: Concurrent chemoirradiation (CCRT)

Sequence chemo and radiation (SCRT)

Experimental group

Description:

Sequence chemotherapy and radiotherapy: 2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

Treatment:

Other: Sequence chemotherapy and radiotherapy (SCRT)