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

• ClinicalTrials.gov Identifier: NCT02595554
• Recruitment Status: Unknown
• First Posted: November 3, 2015
• Last Update Posted: February 3, 2017
• Sponsor: Sun Yat-sen University
• Information provided by (Responsible Party): Jihong Liu, Sun Yat-sen University

Tracking Information

• First Submitted Date: November 2, 2015
• First Posted Date: November 3, 2015
• Last Update Posted Date: February 3, 2017
• Study Start Date: November 2015
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 2, 2015): Disease free survival [ Time Frame: 5 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 2, 2015): Overall survival [ Time Frame: 5 years ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
• Official Title: Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
• 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.
• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Cervical Carcinoma Stage IIB

Intervention

• Radiation: Concurrent chemoirradiation
  External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
• 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

Study Arms

• Active Comparator: Concurrent chemoirradiation (CCRT)
  Concurrent chemoirradiation
  Intervention: Radiation: Concurrent chemoirradiation
• Experimental: NACT+Surgery
  Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery
  Interventions:

  • Drug: Paclitaxel
  • Procedure: Radical Surgery
  • Drug: Cisplatin

• Publications *: Tu H, Huang H, Ouyang Y, Liu Q, Xian B, Song K, Chen G, Shen Y, Liu J. Neoadjuvant chemotherapy followed by radical surgery versus concurrent chemoradiotherapy in patients with FIGO stage IIB cervical cancer: the CSEM 006 study. Int J Gynecol Cancer. 2021 Jan;31(1):129-133. doi: 10.1136/ijgc-2020-001357. Epub 2020 Jun 9.

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 2, 2015): 220
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2020
• Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02595554
• Other Study ID Numbers: CSEM007
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Jihong Liu, Sun Yat-sen University
• Original Responsible Party: Same as current
• Current Study Sponsor: Sun Yat-sen University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Jihong Liu, Ph. D; Sun Yat-sen University

• PRS Account: Sun Yat-sen University
• Verification Date: February 2017