Clinical trial NCT03468010: A Trial Comparing Adjuvant Chemotherapy With Observation After Concurrent Chemoradiotherapy of Cervical Cancer (With Pelvic or Para-aortic Node Involvement)
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Adjuvant Chemotherapy
Radiation
Lymph Node Metastases
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 432
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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 -

Primary outcomes:
measure: 3-year progression-free survival (3y-PFS)
timeFrame: 3 years after the date of adjuvant chemotherapy completion
Secondary outcomes:
measure: Incidence of grade 3/4 adverse event
timeFrame: Once a week during therapy, up to 5 years after the date of adjuvant chemotherapy completion
Other outcomes:
measure: 5-year overall survival (5y-OS)
timeFrame: 5 years after the date of adjuvant chemotherapy completion
Locations:
city: Foshan
country: China
facility: Sun Yat-sen University Affiliated Foshan Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Hospital of of Guangdong Armed Police Corps
state: Guangdong
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Guangzhou
country: China
facility: The First affiliated Hospital of Guangdong Pharmaceutical University
state: Guangdong
city: Guanzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Nanning
country: China
facility: The People's Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Ürümqi
country: China
facility: Xinjiang Medical University Affiliated Tumor Hospital
state: Xinjiang
Study officials:
affiliation: Sun Yat-sen University
name: Wei-jun Ye, M.D
role: PRINCIPAL_INVESTIGATOR
References: