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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03468010
Other study ID # B2017-105-01
Secondary ID
Status Recruiting
Phase Phase 3
First received March 10, 2018
Last updated March 22, 2018
Start date March 1, 2018
Est. completion date March 1, 2025

Study information

Verified date March 2018
Source Sun Yat-sen University
Contact Wei-jun Ye, M.D
Phone 86-13538799871
Email yewj@sysucc.org.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cervical cancer with pelvic or para-aortic node involvement has a poor prognosis. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) 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. Women with evidence of para-aortic node involvement have a poor prognosis with a five-year survival rate of approximately 40 percent. Despite low-quality data, the routine practice to treat these patients is radiation with concurrent cisplatin. It is not clear whether systemic chemotherapy delivered following RT will obtain survival benefit.

2. Objective The aim of this study is to compare systemic chemotherapy with observation after radiation with concurrent cisplatin of cervical cancer ( with pelvic or para-aortic node involvement) for incidence of adverse events, 3y-PFS and 5y-OS, .

3. Patients

A patient will be enrolled when patient have:

1. Pathologically diagnosed cervical cancer;

2. pelvic or para-aortic lymph metastases, at least match one of following

- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter ≥ 7mm in the largest plane

- pelvic or para-aortic lymph node shows necrosis or extra capsular spread

- PET/CT scan finds positive pelvic or para-aortic node lymph node

- biopsy confirms lymph metastase

3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;

4. Karnofsky Performance Scores ≥ 70;

4.Method

1. Randomization is performed to divide the patients into the control group (Group A) and the experimental group (Group B). In Group A, observation is given after radiation with concurrent cisplatin. But in Group B, three cycles of adjuvant chemotherapy ( Paclitaxel plus Cisplatin) are administered after radiation with concurrent cisplatin. The regimen of adjuvant chemotherapy following radiation is Paclitaxel 135mg/m2 plus Cisplatin 60mg/m2 once 3 weeks.The Grade 3/4 adverse events (CTCAE criteria ver. 4.03), the 3-year progression-free survival of the 2 groups, the 5-year overall survival of the 2 groups are compared.

2. In Group A and Group B, both the radiation method and the regimen of concurrent chemotherapy are the same.The gross tumor volume (GTVnd) is the lymph node lesion and given a dose of 60Gy. The clinical target volume (CTV) is according to the lymph drainage pathway and given a dose of 45Gy. The regimen of concurrent chemotherapy is Cisplatin 80mg/m2 once three weeks.


Recruitment information / eligibility

Status Recruiting
Enrollment 432
Est. completion date March 1, 2025
Est. primary completion date March 1, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Pathologically diagnosed cervical cancer;

2. pelvic or para-aortic lymph metastases, at least match one of following

- CT or MRI scan shows pelvic or para-aortic node with a minimal axial diameter diameter = 7mm in the largest plane

- pelvic or para-aortic lymph node shows necrosis or extra capsular spread

- PET/CT scan finds positive pelvic or para-aortic node lymph node

- biopsy confirms lymph metastase

3. Stage IB1-IVA diseases (FIGO system ver. 2014) without treatment before;

4. Karnofsky Performance Scores = 70;

Exclusion Criteria:

1. Patients with distant metastasis before or during radiotherapy

2. Severe dysfunction of heart, lung, liver, kidney or hematopoietic system

3. Severe neurological, mental or endocrine diseases

4. History of other malignancies

5. Those who are considered by the researchers unsuitable to participate -

Study Design


Intervention

Radiation:
chemoradiation
radiation with concurrent ciplatin
Drug:
Paclitaxel, Cisplatin
The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.

Locations

Country Name City State
China Sun Yat-sen University Affiliated Foshan Hospital Foshan 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 Guangzhou First People's Hospital Guanzhou 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 Ürümqi 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
Other 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 adjuvant chemotherapy completion 5 years after the date of adjuvant chemotherapy completion
Primary 3-year progression-free survival (3y-PFS) Percentage of patients in a treatment group who are alive without disease get worse for a 3-year period of follow-up after the date of adjuvant chemotherapy completion 3 years after the date of adjuvant chemotherapy 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 adjuvant chemotherapy completion
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