Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer (SYSGO002)
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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
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Condition or disease | Intervention/treatment | Phase |
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Cervical Carcinoma Stage IIB | Radiation: Concurrent chemoirradiation Drug: Paclitaxel Procedure: Radical Surgery Drug: Cisplatin | Phase 3 |
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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Concurrent chemoirradiation (CCRT)
Concurrent chemoirradiation
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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
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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 |
- Disease free survival [ Time Frame: 5 years ]
- Overall survival [ Time Frame: 5 years ]

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

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
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 |
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 |
Study Director: | Jihong Liu, Ph. D | Sun Yat-sen University |
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 |
Cervical cancer, Stage IIB, Neoadjuvant chemotherapy |
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 |