Comparison of Different Subsequent Treatments After Radical Surgery

NCT00806117 | Unknown Phase 3 DMC

• 1 other identifier: SYSU50102008049
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer

Keywords

Cervical cancer; Concurrent chemoradiation; Randomized controlled clinical trials

Outcome Measures

Primary Outcomes (1)

• Disease Free Survival

  DFS survival analysis

  3-Yr

Secondary Outcomes (1)

• Overall Survival

  5-Yr

Study Arms (3)

Radiotherapy (RT)

ACTIVE COMPARATOR

Radiotherapy

Radiation: Radiotherapy (RT)

Concurrent chemoirradiation (CCRT)

EXPERIMENTAL

Concurrent chemoirradiation: External beam radiation with concurrent weekly platinum chemotherapy

Other: Concurrent chemoirradiation (CCRT)

Sequence chemo and radiation (SCRT)

EXPERIMENTAL

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

Other: Sequence chemotherapy and radiotherapy (SCRT)

Interventions

Radiotherapy (RT) 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)

Radiotherapy (RT)

Concurrent chemoirradiation (CCRT) OTHER

Cisplatin 40mg/m2 every week during external irradiation

Concurrent chemoirradiation (CCRT)

Sequence chemotherapy and radiotherapy (SCRT) OTHER

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

Sequence chemo and radiation (SCRT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Guangdong Provincial People's Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator
• Shenzhen People's Hospital: collaborator
• Cancer Hospital of Guangxi Medical University: collaborator

Study Sites (1)

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

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• 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.

  PMID: 33443541 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jihong Liu, Ph.D.

  Sun Yat-sen University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center

Model Details: 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).

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: February 25, 2008
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: July 30, 2019

Record last verified: 2019-07

Locations

CN (1)