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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3

Conditions: Radiation Therapy; Lymphocyst; Cervical Cancer

Treatments: Drug: Cisplatin; Radiation: Radiation Method B; Radiation: Radiation Method A

Study type: Interventional

Funder types: Other

Identifiers

NCT03071289

N2016203

Details and patient eligibility

About

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.

Full 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.

Enrollment: 540 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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540 participants in 2 patient groups

The control group (Group A)

Active Comparator group

Description:

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.

Treatment:

Radiation: Radiation Method A

Drug: Cisplatin

The experiment group (Group B)

Experimental group

Description:

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.

Treatment:

Radiation: Radiation Method B

Drug: Cisplatin