A Phase 3 interventional study of Radiation Method B and Cisplatin in Cervical Cancer, Lymphocyst and Radiation Therapy, sponsored by Sun Yat-sen University. Recruiting at 8 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2017-07-14.
Sponsored by Sun Yat-sen University · Phase 3, Interventional, and Treatment
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.
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.
A patient will be enrolled when patient have:
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's planned enrollment of 540 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.
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Exclusion Criteria:
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 · Radiation: Radiation Method A
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 · Drug: Cisplatin
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.
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.
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
Time frame: 5 years after the date of radiotherapy completion
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.
Time frame: 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
Time frame: 5 years after the date of radiotherapy completion
Plan to share: No
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