Cervical CancerPhase 3NCT03468010
A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
A Phase 3 study testing chemoradiation and Paclitaxel, Cisplatin in people with Cervical Cancer and Adjuvant Chemotherapy, run by Sun Yat-sen University at 8 sites in China.
Trial summary
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Adjuvant Chemotherapy, Radiation
- What is being tested?
- chemoradiation and Paclitaxel, Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 8 sitesChina
- Study dates
- 1 Mar 2018to 1 Mar 2025
- 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 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically diagnosed cervical cancer;
- pelvic or para-aortic lymph metastases, at least match one of following
- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
- pelvic or para-aortic lymph node shows necrosis or extra capsular spread
- PET/CT scan finds positive pelvic or para-aortic node lymph node
- biopsy confirms lymph metastase
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
Who cannot join
- Patients with distant metastasis before or during radiotherapy
- Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- Severe neurological, mental or endocrine diseases
- History of other malignancies
- Those who are considered by the researchers unsuitable to participate -
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
Sun Yat-sen University Affiliated Foshan Hospital
Foshan, Guangdong
Rong Huang, M.D, 86-13927736853, nnjbhg@163.com
- Not yet recruiting
Hospital of of Guangdong Armed Police Corps
Guangzhou, Guangdong
Zhen-lun Li, M.D, 86-13580516205, sfqiu@126.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Wei-jun Ye, M.D, 86-13538799871, yewj@sysucc.org.cn
Junyun Li, M.D, 86-18824712702, LIJUNY@sysucc.org.cn
- Not yet recruiting
The First affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong
Xi-cheng Wang, M.D, 86-13902400598, 13902400598@126.com
- Not yet recruiting
Guangzhou First People's Hospital
Guanzhou, Guangdong
Guo-long Liu, M.D, 86-13802527172, liugl@fimmu.com
- Not yet recruiting
Hainan General Hospital
Haikou, Hainan
Guang Huang, M.D, 86-18089777161, 2842749787@qq.com
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi
Jia-xin Chen, 86-13978609888, cjx166@163.com
- Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang
Xiao-wen Li, M.D, 86-13899856295, lixiaowen1026@sohu.com
About this study
Official title: Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
Read the detailed description
- Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
- Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
- Patients
A patient will be enrolled when patient have:
- Pathologically diagnosed cervical cancer;
- pelvic or para-aortic lymph metastases, at least match one of following
- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
- pelvic or para-aortic lymph node shows necrosis or extra capsular spread
- PET/CT scan finds positive pelvic or para-aortic node lymph node
- biopsy confirms lymph metastase
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
4.Method
- Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.
- In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.
- Being tested
- chemoradiation, Paclitaxel, Cisplatin
- Medical subject headings
- Uterine Cervical Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoradiationRadiation
radiation with concurrent ciplatin
Paclitaxel, CisplatinDrug
The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| The control group (Group A) | Active comparator | In Group A, observation is given after chemoradiation Receives: Radiation: chemoradiation |
| The experiment group (Group B) | Experimental | in Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks. Receives: Radiation: chemoradiation; Drug: Paclitaxel, Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
3-year progression-free survival (3y-PFS)
Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion
Measured: 3 years after the date of adjuvant chemotherapy completion
Secondary outcomes (1)
Incidence of grade 3/4 adverse event
Incidence of patients in a treatment group who manifest a specific adverse event (such as myelosuppression) of grade 3/4. Incidence is calculated for each adverse event respectively and severity is evaluated on basis of Common Terminology Criteria for Adverse Events (CTCAE) criteria ver. 4.03.
Measured: Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start1 Mar 2018
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei-jun Ye, Sun Yat-sen University
- Investigators
- Wei-jun Ye, M.D, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468010
- Sponsor's protocol ID
- B2017-105-01
- Status last verified
- Mar 2018
- First submitted
- 10 Mar 2018
- Last updated
- 26 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03468010
- Acronym / sponsor ID
- B2017-105-01
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 432 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 16 Mar 2018 (actual)
- 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.
Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events and local recurrence rate.
Detailed description
- Background Cervical Cancer is one of the most common malignant tumors of Chinese females. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.
- Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .
- Patients
A patient will be enrolled when patient have:
- Pathologically diagnosed cervical cancer;
- pelvic or para-aortic lymph metastases, at least match one of following
- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane
- pelvic or para-aortic lymph node shows necrosis or extra capsular spread
- PET/CT scan finds positive pelvic or para-aortic node lymph node
- biopsy confirms lymph metastase
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
4.Method
- Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.
- In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The control group (Group A) | Active comparator | Radiation: chemoradiationIn Group A, observation is given after chemoradiation |
| The experiment group (Group B) | Experimental | Radiation: chemoradiation, Drug: Paclitaxel, Cisplatinin Group B, three cycles of Paclitaxel, Cisplatin are administered after radiation with concurrent cisplatin. The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pathologically diagnosed cervical cancer;
- pelvic or para-aortic lymph metastases, at least match one of following
- Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;
- Karnofsky Performance Scores ≥ 70;
Key exclusion criteria (5 listed)
- Patients with distant metastasis before or during radiotherapy
- Severe dysfunction of heart, lung, liver, kidney or hematopoietic system
- Severe neurological, mental or endocrine diseases
- History of other malignancies
- Those who are considered by the researchers unsuitable to participate -
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 |
|---|---|---|
| chemoradiationradiation with concurrent ciplatin | Radiation | The control group (Group A), The experiment group (Group B) |
| Paclitaxel, CisplatinThe regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks. | Drug | The experiment group (Group B) |
Primary outcome
3-year progression-free survival (3y-PFS)
Time frame: 3 years after the date of adjuvant chemotherapy completion
Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion
1 secondary outcome
Incidence of grade 3/4 adverse event
Time frame: Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Wei-jun Ye, M.D principal investigator
Sun Yat-Sen University Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing chemoradiation and Paclitaxel, Cisplatin in people with Cervical Cancer and Adjuvant Chemotherapy, run by Sun Yat-sen University at 8 sites 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 8 inclusion and 5 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 26 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 Wei-jun Ye, M.D (86-13538799871, yewj@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-year progression-free survival (3y-PFS) (time frame: 3 years after the date of adjuvant chemotherapy completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2018.