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A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03071289
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : July 14, 2017
Sponsor:
Information provided by (Responsible Party):
Wei-jun Ye, Sun Yat-sen University

Brief 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 incidence of adverse events and local recurrence rate.

Condition or disease Intervention/treatment Phase
Cervical Cancer Lymphocyst Radiation Therapy Radiation: Radiation Method B Drug: Cisplatin Radiation: Radiation Method A Phase 3

Detailed Description:
  1. 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.

  2. 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.

  3. Patients and methods

A patient will be enrolled when patient have:

  1. pathologically diagnosed cervical cancer;
  2. Stage I-II diseases (FIGO system ver. 2014);
  3. treated with radical resection;
  4. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 540 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
Actual Study Start Date : June 1, 2017
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin

Arm Intervention/treatment
Active Comparator: The control group (Group A)
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.
Drug: Cisplatin
The regimen of chemotherapy is cisplatin 30mg/m2 every week.

Radiation: Radiation Method A
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.

Experimental: The experiment group (Group B)
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.
Radiation: Radiation Method B
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.

Drug: Cisplatin
The regimen of chemotherapy is cisplatin 30mg/m2 every week.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Incidence of grade 3/4 adverse event [ Time Frame: Once a week during therapy, up to 5 years after the date of radiotherapy completion ]
    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.

  2. 5-year overall survival (5y-OS) [ Time Frame: 5 years after the date of radiotherapy completion ]
    Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of radiotherapy completion



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

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): NCT03071289


Contacts
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Contact: Wei-jun Ye, M.D 86-13538799871 yewj@sysucc.org.cn
Contact: Hui Chang, M.D 86-13480295989 changhui@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Affiliated Foshan Hospital Not yet recruiting
Foshan, Guangdong, China, 528000
Contact: Rong Huang, M.D    86-13927736853    nnjbhg@163.com   
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Wei-jun Ye, M.D    86-13538799871    yewj@sysucc.org.cn   
Contact: Hui Chang, M.D    86-13480295989    changhui@sysucc.org.cn   
The First affiliated Hospital of Guangdong Pharmaceutical University Not yet recruiting
Guangzhou, Guangdong, China, 510080
Contact: Xi-cheng Wang, M.D    86-13902400598    13902400598@126.com   
Guangzhou First People's Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510180
Contact: Guo-long Liu, M.D    86-13802527172    liugl@fimmu.com   
Hospital of of Guangdong Armed Police Corps Not yet recruiting
Guangzhou, Guangdong, China, 510507
Contact: Zhen-lun Li, M.D    86-13580516205    sfqiu@126.com   
China, Guangxi
The People's Hospital of Guangxi Zhuang Autonomous Region Not yet recruiting
Nanning, Guangxi, China, 530021
Contact: Jia-xin Chen, M.D    86-13978609888    cjx166@163.com   
China, Hainan
Hainan General Hospital Not yet recruiting
Haikou, Hainan, China, 570311
Contact: Guang Huang, M.D    86-18089777161    2842749787@qq.com   
China, Xinjiang
Xinjiang Medical University Affiliated Tumor Hospital Not yet recruiting
Wulumuqi, Xinjiang, China, 830000
Contact: Xiao-wen Li, M.D    86-13899856295    lixiaowen1026@sohu.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Wei-jun Ye, M.D Sun Yat-sen University
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Responsible Party: Wei-jun Ye, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03071289    
Other Study ID Numbers: N2016203
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: July 14, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Lymphocele
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Cysts
Lymphatic Diseases
Cisplatin
Antineoplastic Agents