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

July 11, 2017 updated by: Wei-jun Ye, Sun Yat-sen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

540

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Not yet recruiting
        • Sun Yat-sen University Affiliated Foshan Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Sun Yat-Sen University Cancer Center
        • Contact:
        • Contact:
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
      • Guangzhou, Guangdong, China, 510080
        • Not yet recruiting
        • The First Affiliated Hospital of Guangdong Pharmaceutical University
        • Contact:
      • Guangzhou, Guangdong, China, 510507
        • Not yet recruiting
        • Hospital of of Guangdong Armed Police Corps
        • Contact:
          • Zhen-lun Li, M.D
          • Phone Number: 86-13580516205
          • Email: sfqiu@126.com
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
          • Jia-xin Chen, M.D
          • Phone Number: 86-13978609888
          • Email: cjx166@163.com
    • Hainan
      • Haikou, Hainan, China, 570311
        • Not yet recruiting
        • Hainan General Hospital
        • Contact:
    • Xinjiang
      • Wulumuqi, Xinjiang, China, 830000
        • Not yet recruiting
        • Xinjiang Medical University Affiliated Tumor Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: The control group (Group A)
In Group A, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method A. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
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.
EXPERIMENTAL: The experiment group (Group B)
In Group B, adjuvant radio-chemotherapy is applied. The radiotherapy is performed according to Radiation Method B. The regimen of chemotherapy is cisplatin 30mg/m2 every week.
Drug: Cisplatin
The regimen of chemotherapy is cisplatin 30mg/m2 every week.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years after the date of radiotherapy completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Once a week during therapy, up to 5 years after the date of radiotherapy completion
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
5 years after the date of radiotherapy completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Wei-jun Ye, M.D, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ANTICIPATED)

March 31, 2025

Study Completion (ANTICIPATED)

March 31, 2025

Study Registration Dates

First Submitted

March 1, 2017

First Submitted That Met QC Criteria

March 3, 2017

First Posted (ACTUAL)

March 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 11, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N2016203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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