Cervical Cancer Clinical Trial
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.
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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