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Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer (SYSGO002)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02595554
Recruitment Status : Unknown
Verified February 2017 by Jihong Liu, Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : November 3, 2015
Last Update Posted : February 3, 2017
Sponsor:
Information provided by (Responsible Party):
Jihong Liu, Sun Yat-sen University

Study Description
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Brief Summary:
Neoadjuvant chemotherapy (NACT) and radical surgery (RS) may have a possible better outcome to concurrent chemoirradiation (CCRT) in stage IIB cervical cancer. We try to verify such a hypothesis in terms of survival and treatment related morbidity.

Condition or disease Intervention/treatment Phase
Cervical Carcinoma Stage IIB Radiation: Concurrent chemoirradiation Drug: Paclitaxel Procedure: Radical Surgery Drug: Cisplatin Phase 3

Detailed Description:
Patients with International Federation of Gynecology and Obstetrics (FIGO) stage IIB cervical cancer are eligible for our study. They will receive cisplatin based neoadjuvant chemotherapy (NACT) 3 cycles followed by radical surgery (RS) (type III to V radical hysterectomy plus systematic pelvic lymphadenectomy) (arm A) or external beam radiation (EBRT) with concurrent weekly platinum 40mg/m2 followed by brachyradiotherapy (arm B).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
Study Start Date : November 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Concurrent chemoirradiation (CCRT)
Concurrent chemoirradiation
 Radiation: Concurrent chemoirradiation
External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
Experimental: NACT+Surgery
Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
 Drug: Paclitaxel
New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
Other Name: NACT

Procedure: Radical Surgery
Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
Other Name: NACT and surgery

Drug: Cisplatin
New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
Other Name: NACT


Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: 5 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with newly histologically confirmed cervical carcinoma
  • Original clinical stage must be IIB （FIGO 2009）
  • Histopathology squamous carcinoma, adenocarcinoma or adeno-squamous carcinoma
  • Age between 18-65
  • Patients must give signed informed consent

Exclusion Criteria:

  • The presence of uncontrolled life-threatening illness
  • Receiving other ways of anti-cancer therapy
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595554


Contacts
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Contact: Jihong Liu, Ph. D 86-20-87343102 Liujih@mail.sysu.edu.cn
Contact: He Huang, Ph. D 86-20-87343014 Huangh@sysucc.org.cn

Locations
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China, Guangdong
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Jihong Liu, Ph.D.    86-20-87343102    Liujih@mail.sysu.edu.cn   
Contact: He Huang, Ph.D.    86-20-87343104    huangh@sysucc.org.cn   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Study Director: Jihong Liu, Ph. D Sun Yat-sen University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Jihong Liu, Sun Yat-sen University Cancer Center, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT02595554    
Other Study ID Numbers: CSEM007
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: February 3, 2017
Last Verified: February 2017
Keywords provided by Jihong Liu, Sun Yat-sen University:
Cervical cancer, Stage IIB, Neoadjuvant chemotherapy
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
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
Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action