A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
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|ClinicalTrials.gov Identifier: NCT03071289|
Recruitment Status : Recruiting
First Posted : March 6, 2017
Last Update Posted : July 14, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Lymphocyst Radiation Therapy||Radiation: Radiation Method B Drug: Cisplatin Radiation: Radiation Method A||Phase 3|
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.
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||540 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
The regimen of chemotherapy is cisplatin 30mg/m2 every week.
- 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
- 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.
- 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
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
|Contact: Wei-jun Ye, M.Dfirstname.lastname@example.org|
|Contact: Hui Chang, M.Demail@example.com|
|Sun Yat-sen University Affiliated Foshan Hospital||Not yet recruiting|
|Foshan, Guangdong, China, 528000|
|Contact: Rong Huang, M.D 86-13927736853 firstname.lastname@example.org|
|Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Wei-jun Ye, M.D 86-13538799871 email@example.com|
|Contact: Hui Chang, M.D 86-13480295989 firstname.lastname@example.org|
|The First affiliated Hospital of Guangdong Pharmaceutical University||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Xi-cheng Wang, M.D 86-13902400598 email@example.com|
|Guangzhou First People's Hospital||Not yet recruiting|
|Guangzhou, Guangdong, China, 510180|
|Contact: Guo-long Liu, M.D 86-13802527172 firstname.lastname@example.org|
|Hospital of of Guangdong Armed Police Corps||Not yet recruiting|
|Guangzhou, Guangdong, China, 510507|
|Contact: Zhen-lun Li, M.D 86-13580516205 email@example.com|
|The People's Hospital of Guangxi Zhuang Autonomous Region||Not yet recruiting|
|Nanning, Guangxi, China, 530021|
|Contact: Jia-xin Chen, M.D 86-13978609888 firstname.lastname@example.org|
|Hainan General Hospital||Not yet recruiting|
|Haikou, Hainan, China, 570311|
|Contact: Guang Huang, M.D 86-18089777161 email@example.com|
|Xinjiang Medical University Affiliated Tumor Hospital||Not yet recruiting|
|Wulumuqi, Xinjiang, China, 830000|
|Contact: Xiao-wen Li, M.D 86-13899856295 firstname.lastname@example.org|
|Principal Investigator:||Wei-jun Ye, M.D||Sun Yat-sen University|