A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)

Cervical Cancer Clinical Trial

Official title:

Adjuvant Chemotherapy Versus Observation After Radiation With Concurrent Cisplatin of Cervical Cancer (With Pelvic or Para-aortic Node Involvement) :A Phase 3 Prospective Multi-institutional Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03468010
• Other study ID #: B2017-105-01
• 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
• 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 -

Related Conditions & MeSH terms

• Adjuvant Chemotherapy
• Cervical Cancer
• Lymph Node Metastases
• Radiation
• Uterine Cervical Neoplasms

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