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

Sun Yat-sen University540 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Conditions

Cervical Cancer Lymphocyst Radiation Therapy

Interventions

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (8)

Sun Yat-sen University Affiliated Foshan Hospital

Foshan, Guangdong, China

NOT_YET_RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

The First affiliated Hospital of Guangdong Pharmaceutical University

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Wei-jun Ye, M.D

CONTACT

86-13538799871 yewj@sysucc.org.cn

Hui Chang, M.D

CONTACT

86-13480295989 changhui@sysucc.org.cn

Data from ClinicalTrials.gov

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