Cervical CancerPhase 3NCT03071289
A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
A Phase 3 study testing Radiation Method B, Cisplatin and Radiation Method A in people with Cervical Cancer and Lymphocyst, run by Sun Yat-sen University at 8 sites in China.
Trial summary
Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Cervical Cancer, Lymphocyst, Radiation Therapy
- What is being tested?
- Radiation Method B, Cisplatin and Radiation Method A
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 8 sitesChina
- Study dates
- 1 Jun 2017to 31 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
- Patients with pathological diagnosed cervical cancer and treated with radical resection
- Stage I-II diseases (FIGO system ver. 2014)
- Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months
- Pelvic MRI or CT indicate existence of lymphocyst
- Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria)
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
- Prior chemotherapy, radiotherapy or application of monoclonal antibodies
- Patients participated in clinical trials of other drugs within last 3 months
- Pregnant or lactating women
- 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, 528000
Rong Huang, M.D, 86-13927736853, nnjbhg@163.com
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Wei-jun Ye, M.D, 86-13538799871, yewj@sysucc.org.cn
Hui Chang, M.D, 86-13480295989, changhui@sysucc.org.cn
- Not yet recruiting
The First affiliated Hospital of Guangdong Pharmaceutical University
Guangzhou, Guangdong, 510080
Xi-cheng Wang, M.D, 86-13902400598, 13902400598@126.com
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Guo-long Liu, M.D, 86-13802527172, liugl@fimmu.com
- Not yet recruiting
Hospital of of Guangdong Armed Police Corps
Guangzhou, Guangdong, 510507
Zhen-lun Li, M.D, 86-13580516205, sfqiu@126.com
- Not yet recruiting
Hainan General Hospital
Haikou, Hainan, 570311
Guang Huang, M.D, 86-18089777161, 2842749787@qq.com
- Not yet recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021
Jia-xin Chen, M.D, 86-13978609888, cjx166@163.com
- Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830000
Xiao-wen Li, M.D, 86-13899856295, lixiaowen1026@sohu.com
About this study
Official title: Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
Cervical cancer of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, 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. The early stage diseases (Stage Ia, Ib and IIa1) is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events (incidence 18-35%) of radical resection. When adjuvant radiotherapy (ART) is performed, lymphocyst is included in the clinical target volume (CTV) with a dose of 45-50Gy, in most hospitals of China. However, there is no pathologic and clinical evidence that lymphocyst is associated with local recurrence. However, inclusion of lymphocyst might enlarge CTV and increase irradiation dose of organs at risk (OARs) such as small intestine and kidneys.
- Objective The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
- Patients and methods
A patient will be enrolled when patient have:
- pathologically diagnosed cervical cancer;
- Stage I-II diseases (FIGO system ver. 2014);
- treated with radical resection;
- need of ART according to NCCN guidelines ver. 2016v2.
Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, the CTV includes all the lymphocyst. But in Group B, the CTV is delineated according to the lymph drainage pathway (not all the lymphocyst included). ART is performed with a dose of 60Gy to the gross tumor volume, and 45Gy to the CTV. Chemotherapy is given concurrently with cisplatin 30mg/m2 every week regimen. The Grade 3/4 adverse events (CTCAE criteria ver. 4.03) and the 5-year local-recurrence-free survival of the 2 groups are compared after 5-year follow-up with an interval of 3 months.
- Conditions
- Cervical Cancer, Lymphocyst, Radiation Therapy
- Being tested
- Radiation Method B, Cisplatin, Radiation Method A
- Medical subject headings
- Uterine Cervical Neoplasms, Lymphocele
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation Method BRadiation
The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and included all the lymphocyst. The CTV is given a dose of 45Gy.
CisplatinDrug
The regimen of chemotherapy is cisplatin 30mg/m2 every week.
Radiation Method ARadiation
The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and given a dose of 45Gy.
| Study group | Role | What they receive |
|---|---|---|
| The control group (Group A) | Active comparator | In Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week. Receives: Drug: Cisplatin; Radiation: Radiation Method A |
| The experiment group (Group B) | Experimental | In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week. Receives: Radiation: Radiation Method B; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
5-year local-recurrence-free survival (5y-LRFS)
Percentage of patients in a treatment group who are alive without local recurrence for a 5-year period of follow-up after the date of radiotherapy completion
Measured: 5 years after the date of radiotherapy completion
Secondary outcomes (2)
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 radiotherapy completion
5-year overall survival (5y-OS)
Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of radiotherapy completion
Measured: 5 years after the date of radiotherapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study start1 Jun 2017
- Primary completion31 Mar 2025 (estimated)
- Study completion31 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
- 540 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
- NCT03071289
- Sponsor's protocol ID
- N2016203
- Status last verified
- Jul 2017
- First submitted
- 1 Mar 2017
- Last updated
- 14 Jul 2017
- 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 14 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03071289
- Acronym / sponsor ID
- N2016203
- Conditions
- Cervical Cancer, Lymphocyst, Radiation Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 6 Mar 2017 (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 of early stage is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events of radical resection. The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, 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. The early stage diseases (Stage Ia, Ib and IIa1) is treated mainly by radical resection and (or) radiotherapy. And pelvic lymphocyst is one of the most common adverse events (incidence 18-35%) of radical resection. When adjuvant radiotherapy (ART) is performed, lymphocyst is included in the clinical target volume (CTV) with a dose of 45-50Gy, in most hospitals of China. However, there is no pathologic and clinical evidence that lymphocyst is associated with local recurrence. However, inclusion of lymphocyst might enlarge CTV and increase irradiation dose of organs at risk (OARs) such as small intestine and kidneys.
- Objective The aim of this study is to compare observation with radiation on pelvic lymphocyst of cervical cancer patients after radical resection, for incidence of adverse events and local recurrence rate.
- Patients and methods
A patient will be enrolled when patient have:
- pathologically diagnosed cervical cancer;
- Stage I-II diseases (FIGO system ver. 2014);
- treated with radical resection;
- need of ART according to NCCN guidelines ver. 2016v2.
Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, the CTV includes all the lymphocyst. But in Group B, the CTV is delineated according to the lymph drainage pathway (not all the lymphocyst included). ART is performed with a dose of 60Gy to the gross tumor volume, and 45Gy to the CTV. Chemotherapy is given concurrently with cisplatin 30mg/m2 every week regimen. The Grade 3/4 adverse events (CTCAE criteria ver. 4.03) and the 5-year local-recurrence-free survival of the 2 groups are compared after 5-year follow-up with an interval of 3 months.
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 | Drug: Cisplatin, Radiation: Radiation Method AIn Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week. |
| The experiment group (Group B) | Experimental | Radiation: Radiation Method B, Drug: CisplatinIn Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with pathological diagnosed cervical cancer and treated with radical resection
- Stage I-II diseases (FIGO system ver. 2014)
- Karnofsky Performance Scores ≥ 80 and expected survival ≥ 3 months
- Pelvic MRI or CT indicate existence of lymphocyst
- Need of adjuvant radiotherapy according to NCCN guidelines ver. 2016v2 (SEDLIS criteria)
Key exclusion criteria (8 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
- Prior chemotherapy, radiotherapy or application of monoclonal antibodies
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 |
|---|---|---|
| Radiation Method BThe gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and included all the lymphocyst. The CTV is given a dose of 45Gy. | Radiation | The experiment group (Group B) |
| CisplatinThe regimen of chemotherapy is cisplatin 30mg/m2 every week. | Drug | The control group (Group A), The experiment group (Group B) |
| Radiation Method AThe gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and given a dose of 45Gy. | Radiation | The control group (Group A) |
Primary outcome
5-year local-recurrence-free survival (5y-LRFS)
Time frame: 5 years after the date of radiotherapy completion
Percentage of patients in a treatment group who are alive without local recurrence for a 5-year period of follow-up after the date of radiotherapy completion
2 secondary outcomes
Incidence of grade 3/4 adverse event
Time frame: Once a week during therapy, up to 5 years after the date of radiotherapy completion
5-year overall survival (5y-OS)
Time frame: 5 years after the date of radiotherapy completion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
- 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 Radiation Method B, Cisplatin and Radiation Method A in people with Cervical Cancer and Lymphocyst, 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 5 inclusion and 8 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 14 Jul 2017. 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?
5-year local-recurrence-free survival (5y-LRFS) (time frame: 5 years after the date of radiotherapy 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 14 Jul 2017.