Clinical trial NCT03071289: A Trial Comparing Observation With Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer
Official title: Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Lymphocyst
Radiation Therapy
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2017-03-06
Enrollment: 540
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: 5-year local-recurrence-free survival (5y-LRFS)
timeFrame: 5 years after the date of radiotherapy completion
Secondary outcomes:
measure: Incidence of grade 3/4 adverse event
timeFrame: Once a week during therapy, up to 5 years after the date of radiotherapy completion
measure: 5-year overall survival (5y-OS)
timeFrame: 5 years after the date of radiotherapy completion
Other outcomes:
Locations:
city: Foshan
country: China
facility: Sun Yat-sen University Affiliated Foshan Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Hospital of of Guangdong Armed Police Corps
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wulumuqi
country: China
facility: Xinjiang Medical University Affiliated Tumor Hospital
state: Xinjiang
Study officials:
affiliation: Sun Yat-sen University
name: Wei-jun Ye, M.D
role: PRINCIPAL_INVESTIGATOR
References: