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

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03071289
• Other study ID #: N2016203
• Status: Recruiting
• Phase: Phase 3
• First received: March 1, 2017
• Last updated: July 11, 2017
• Start date: June 1, 2017
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: Wei-jun Ye, M.D
• Phone: 86-13538799871
• Email: yewj[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 540
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Lymphocele
• Lymphocyst
• Radiation Therapy
• Uterine Cervical Neoplasms

Intervention

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.

Drug:
• Cisplatin
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.

Locations

Country	Name	City	State
China	Sun Yat-sen University Affiliated Foshan Hospital	Foshan	Guangdong
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	Hospital of of Guangdong Armed Police Corps	Guangzhou	Guangdong
China	Sun Yat-sen University Cancer Center	Guangzhou	Guangdong
China	The First affiliated Hospital of Guangdong Pharmaceutical University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	The People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi
China	Xinjiang Medical University Affiliated Tumor Hospital	Wulumuqi	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	5 years after the date of radiotherapy completion
Secondary	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.	Once a week during therapy, up to 5 years after the date of radiotherapy completion
Secondary	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	5 years after the date of radiotherapy completion