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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Observation Versus Radiation on Pelvic Lymphocysts After Radical Hysterectomy of Cervical Cancer: A Phase 3 Prospective Multi-institutional Randomised Controlled Trial

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 Summary:

  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, th
Sponsor: Sun Yat-sen University

Current Primary Outcome: 5-year local-recurrence-free survival (5y-LRFS) [ Time Frame: 5 years after the date of radiotherapy completion ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of grade 3/4 adverse event [ Time Frame: Once a week during therapy, up to 5 years after the date of radiotherapy completion ]
    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.
  • 5-year overall survival (5y-OS) [ Time Frame: 5 years after the date of radiotherapy completion ]
    Percentage of patients in a treatment group who are alive for a 5-year period of follow-up after the date of radiotherapy completion


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: March 1, 2017
Date Started: April 1, 2017
Date Completion: March 31, 2025
Last Updated: March 3, 2017
Last Verified: March 2017