Cervical Carcinoma Stage IIBPhase 3SYSGO002NCT02595554
Neoadjuvant Chemotherapy and Radical Surgery in Stage IIB Cervical Cancer
A Phase 3 study testing Concurrent chemoirradiation, Paclitaxel and Radical Surgery in people with Cervical Carcinoma Stage IIB, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Carcinoma Stage IIB
- What is being tested?
- Concurrent chemoirradiation, Paclitaxel and Radical Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Nov 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Gynecologic Oncology, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jihong Liu, Ph.D., 86-20-87343102, Liujih@mail.sysu.edu.cn
He Huang, Ph.D., 86-20-87343104, huangh@sysucc.org.cn
About this study
Official title: Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
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.
Read the 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).
- Conditions
- Cervical Carcinoma Stage IIB
- Being tested
- Concurrent chemoirradiation, Paclitaxel, Radical Surgery, Cisplatin
- Keywords
- Cervical cancer, Stage IIB, Neoadjuvant chemotherapy
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent chemoirradiationRadiation
External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
PaclitaxelDrug
Also called NACT
New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
Radical SurgeryProcedure or surgery
Also called NACT and surgery
Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
CisplatinDrug
Also called NACT
New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Concurrent chemoirradiation (CCRT) | Active comparator | Concurrent chemoirradiation Receives: Radiation: Concurrent chemoirradiation |
| NACT+Surgery | Experimental | Neoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery Receives: Drug: Paclitaxel; Procedure: Radical Surgery; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: 5 years
Secondary outcomes (1)
Overall survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical Carcinoma Stage IIBStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jihong Liu, Sun Yat-sen University
- Investigators
- Jihong Liu, Ph. D, Study director, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02595554
- Sponsor's protocol ID
- CSEM007
- Acronym
- SYSGO002
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2015
- Last updated
- 3 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 32522771
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Chemotherapy and Radical Surgery Versus Concurrent Chemoirradiation in FIGO Stage IIB Cervical Cancer
- ClinicalTrials.gov ID
- NCT02595554
- Acronym / sponsor ID
- SYSGO002 / CSEM007
- Conditions
- Cervical Carcinoma Stage IIB
- Keywords
- Cervical cancer, Stage IIB, Neoadjuvant chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 3 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent chemoirradiation (CCRT) | Active comparator | Radiation: Concurrent chemoirradiationConcurrent chemoirradiation |
| NACT+Surgery | Experimental | Drug: Paclitaxel, Procedure: Radical Surgery, Drug: CisplatinNeoadjuvant chemotherapy with Paclitaxel and Cisplatin (3 cycles), followed by radical surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent chemoirradiationExternal beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy | Radiation | Concurrent chemoirradiation (CCRT) |
| PaclitaxelAlso: NACTNew adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin | Drug | NACT+Surgery |
| Radical SurgeryAlso: NACT and surgeryRadical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling | Procedure or surgery | NACT+Surgery |
| CisplatinAlso: NACTNew adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2 | Drug | NACT+Surgery |
Primary outcome
Disease free survival
Time frame: 5 years
1 secondary outcome
Overall survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2017.
- Derived from this study: PubMed 32522771Tu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihong Liu, Ph. D study director
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Concurrent chemoirradiation, Paclitaxel and Radical Surgery in people with Cervical Carcinoma Stage IIB, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jihong Liu, Ph. D (86-20-87343102, Liujih@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02595554, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2017; AzTrials last refreshed its copy on 7 Nov 2026.