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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparison of Pelvic Lymphadenectomy Versus Isolated Sentinel Lymph Node Biopsy Procedure for Early Stages of Cervical Cancers : a Multicenter Study With Evaluation of Medico-economic Impacts

NCT01639820

Uterine Cervical Dysplasia

COMPLETED NA

Clinical Trial of Laparoscopic Pelvic and Para-aortic Lymphadenectomy and Uterine Blood Vessel Blocking for Precision Diagnosis and Treatment in Advanced Cervical Cancer

NCT02950350

Cervical Cancer, Stage IIB Cervical Cancer Stage IIIA Cervical Cancer Stage IIIB +1 more

UNKNOWN

Different Surgical Approaches in Patients of Early-stage Cervical Cancer

NCT03739944

Uterine Cervical Neoplasm Laparotomy Laparoscopy +6 more

UNKNOWN PHASE3

Sentinel Lymph Nodes Biopsy in Cervical Cancer

NCT06169787

Sentinel Lymph Node

ACTIVE_NOT_RECRUITING

Exclusion of Non-involved Uterus From the Target Volume in Locally Advanced Cervical Cancer

NCT03542942

Uterine Cervical Neoplasms

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cervical Cancer Lymphocyst Radiation Therapy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Cisplatin

Intervention Type DRUG

The regimen of chemotherapy is cisplatin 30mg/m2 every week.

Radiation Method A

Intervention Type RADIATION

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.

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.

Group Type EXPERIMENTAL

Radiation Method B

Intervention Type RADIATION

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.

Cisplatin

Intervention Type DRUG

The regimen of chemotherapy is cisplatin 30mg/m2 every week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type RADIATION

Cisplatin

The regimen of chemotherapy is cisplatin 30mg/m2 every week.

Intervention Type DRUG

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.

Intervention Type RADIATION

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No