Comparison of Different Subsequent Treatments After Radical Surgery

NCT ID: NCT00806117

Last Updated: 2019-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 1080 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-25
• Study Completion Date: 2020-12-31

Brief 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.

Conditions

Cervical Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Radiotherapy (RT)

Radiotherapy

Group Type: ACTIVE_COMPARATOR

Radiotherapy (RT)

Intervention Type: RADIATION

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)

Concurrent chemoirradiation (CCRT)

Concurrent chemoirradiation:

External beam radiation with concurrent weekly platinum chemotherapy

Group Type: EXPERIMENTAL

Concurrent chemoirradiation (CCRT)

Intervention Type: OTHER

Cisplatin 40mg/m2 every week during external irradiation

Sequence chemo and radiation (SCRT)

Sequence chemotherapy and radiotherapy:

2 cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation

Group Type: EXPERIMENTAL

Sequence chemotherapy and radiotherapy (SCRT)

Intervention Type: OTHER

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

Interventions

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)

Intervention Type: RADIATION

Concurrent chemoirradiation (CCRT)

Cisplatin 40mg/m2 every week during external irradiation

Intervention Type: OTHER

Sequence chemotherapy and radiotherapy (SCRT)

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Guangdong Provincial People's Hospital

OTHER

Sponsor Role: collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Shenzhen People's Hospital

OTHER

Sponsor Role: collaborator

Cancer Hospital of Guangxi Medical University

OTHER

Sponsor Role: collaborator

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Jihong Liu

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jihong Liu, Ph.D.

Role: STUDY_CHAIR

Sun Yat-sen University

Locations

Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Countries

China

References

Huang H, Feng YL, Wan T, Zhang YN, Cao XP, Huang YW, Xiong Y, Huang X, Zheng M, Li YF, Li JD, Chen GD, Li H, Chen YL, Ma LG, Yang HY, Li L, Yao SZ, Ye WJ, Tu H, Huang QD, Liang LZ, Liu FY, Liu Q, Liu JH. Effectiveness of Sequential Chemoradiation vs Concurrent Chemoradiation or Radiation Alone in Adjuvant Treatment After Hysterectomy for Cervical Cancer: The STARS Phase 3 Randomized Clinical Trial. JAMA Oncol. 2021 Mar 1;7(3):361-369. doi: 10.1001/jamaoncol.2020.7168.

Reference Type: DERIVED

PMID: 33443541 (View on PubMed)

Other Identifiers

SYSU50102008049

Identifier Type: -

Identifier Source: org_study_id