Comparison of Different Subsequent Treatments After Radical Surgery (STARS)

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

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.

Study Overview

• Status: Unknown
• Conditions: Cervical Cancer
• Intervention / Treatment: Radiation: Radiotherapy (RT); Other: Concurrent chemoirradiation (CCRT); Other: Sequence chemotherapy and radiotherapy (SCRT)

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.

• Study Type: Interventional
• Enrollment (Actual): 1080
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Radiotherapy (RT); Radiotherapy	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)
Experimental: Concurrent chemoirradiation (CCRT); Concurrent chemoirradiation: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Free Survival	DFS survival analysis	3-Yr

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival	OS survival analysis	5-Yr

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: First Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial People's Hospital; Shenzhen People's Hospital; Cancer Hospital of Guangxi Medical University
• Investigators: Study Chair: Jihong Liu, Ph.D., Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2008
• Primary Completion (Actual): December 31, 2018
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: December 8, 2008
• First Submitted That Met QC Criteria: December 9, 2008
• First Posted (Estimate): December 10, 2008

Study Record Updates

• Last Update Posted (Actual): July 30, 2019
• Last Update Submitted That Met QC Criteria: July 28, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Concurrent chemoradiation; Cervical cancer; Randomized controlled clinical trials
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: SYSU50102008049